A Guide to the Mutual Recognition Agreement between the European Community and Japan

Transcription

1 Presented to EUROPEAN COMMISSION Directorate-General for Trade A Guide to the Mutual Recognition Agreement between the European Community and Japan September 2003 Submitted by MTA Japan Co., Ltd. & Mitsubishi Research Institute, Inc. Copyright European Commission All rights reserved. Copying and Reproduction of this material is strictly prohibited.

2 Doing Business in Japan Conformity Assessment Guide for: European industry EU conformity assessment bodies EU designating authorities Important notice This Guide contains the available information at the moment of final drafting. Readers can obtain updated information by visiting the relevant web-pages. Web-site of the Directorate General for Trade can be found at: Web-site of the Directorate General for Enterprise can be found at: This guide was prepared with financial assistance from the Commission of the European Communities. The views expressed herein are those of the Contractor and do not represent any official view of the Commission. MTA Japan Co., Ltd. #201, 2-1-3, Horidome-cho Nihonbashi, Chuo-ku Tokyo Japan European Commission Reproduction is authorized provided the source is acknowledged. ii

3 Foreward The European Union (EU) and Japan concluded an agreement on mutual recognition (MRA) which entered into force on 1 st January The MRA has the overriding objective of promoting trade in goods between the EU and Japan by facilitating market access. The EU-Japan MRA covers the following sectors: Telecommunication Terminal Equipment and Radio Equipment, Electrical Products, Good Laboratory Practice (GLP) for Chemical Products and Good Manufacturing Practice (GMP) for Medicinal Products. MTA Japan Co., Ltd. and Mitsubishi Research Institute, Inc. prepared this Guide to EU-Japan MRA with financial assistance from the Commission of the European Communities. The views expressed herein are those of the author, and do not represent any official view of the Commission. The EU-Japan MRA is based on the relevant legislation, regulations and administrative provisions of these parties. Those legal acts evolve over time and the MRA is also modified to reflect such changes. It is always the current legal acts in force that apply. This guide reflects the status on such its date of publication. Uses of this guide should therefore ensure that they have available the current legislative, regulatory and administrative documents. Information on where this is available is provided herein. The MRA lays down the conditions under which the EU and Japan will accept certificates of conformity issued by the conformity assessment bodies (CABs) of the other party according to the requirements of the importing party. This means that a manufacturer wherever located can have its product tested and certified according to a Japanese requirement by a CAB located in the EU. This will permit manufacturers to turn to European CABs they are familiar with and thus avoid the burden, cost and time associated with having to seek out the service of a body in Japan. European CABs will in their turn to be given the possibility of offering more comprehensive services. The MRA does not call for a harmonization of product or conformity assessment requirements between the EU and Japan. Each party maintains its own legislation and regulatory requirements. The smooth functioning of the agreement therefore requires that both sides have full knowledge and understanding of the other party s legislative, regulatory and administrative requirements. From the European point of view, the objective of the EU-Japan MRA is to give benefits to European manufacturing industry in terms of more direct market access for their products in Japan. To achieve this objective, key players in Europe must become aware of the possibilities the MRA ii

4 offers and have correct and timely information in order to take advantage of the agreement. Key players in this regard are designating authorities at the Member State level, the CABs and the European manufacturing industry itself, including but not limited to SMEs. Late in 1999, the Commission services concluded that it would be useful for Member States, European CABs and industry to have the benefits of a guide with clear and practical information on the MRA. Such a guide, the Commission believed, would advance the two goals of the smooth functioning of the agreement and the more direct access for European industry to the Japanese marketplace. The Guide begins with a background and context for the EU-Japan MRA and follows as; Chapter 2 Structure and Content of MRA, Chapter 3 Structure and Understanding the MRA Law Established in Japan Chapter 4 Japan s Standards and Conformity Assessment Infrastructure. Each chapter contains a comprehensive list of European and Japanese organizational contacts for further information. Each chapter includes reference text of applicable sectoral Annexes to the MRA including amendments current through June MTA Japan Co., Ltd. and Mitsubishi Research Institute Inc. gratefully acknowledge the significant assistance of many government and private sector contributors and reviewers of this document during its evolution. Such a guide as this would be impossible to produce without the cooperation and support of responsible regulatory authorities, conformity assessment organizations and concerned industries and their associations. MTA Japan Co., Ltd. Yumi Shindo, Project Manager and Director Address: #201, Horidomecho Nihonbashi, Chuo-Ku, Tokyo Japan Tel: (03) Fax: (03) E Mail: 17025@mtajpn.com & Mitsubishi Research Institute, Inc. Kenji Takahashi, Research Director General Address: 3-6 Otemachi, 2-Chome, Chiyoda-Ku,Tokyo Japan Tel: (03) Fax: (03) nicklaus@mri.co.jp iii

5 Acronyms AS NITE Accreditation System of National Institute of Technology and Evaluation CAB Conformity Assessment Body CSCL Chemical Substances Control Law EMC Electromagnetic Compatibility GCP Good Clinical Practice GLP Good Laboratory Practice GMP Good Manufacturing Practice IA Japan International Accreditation Japan JAB the Japan Accreditation Board for Conformity Assessment JATE Japan Approval Institute for Telecommunication Equipment JCLA Japan Chemical Laboratory Accreditation JCSS Japan Calibration Service System JECTEC Japan Electric Cable Technology Center, Inc. JET Japan Electrical Safety and Environment JIS Japan Industrial Standards JNLA Japan National Laboratory Accreditation JQA Japan Quality Assurance Organization METI Ministry of Economy, Trade and Industry MPHPT Ministry of Public Management, Home Affairs, Posts and Telecommunications MRA Mutual Recognition Agreement NITE National Institute of Technology and Evaluation OPSR Organization for Pharmaceutical Safety and Research Center PAFSC Pharmaceutical Affairs and Food Sanitation Council PMDEC Pharmaceutical and Medical Devices Evaluation Center TELEC Telecom Engineering Center VLAC Voluntary EMC Laboratory Accreditation Center, Inc. iv

6 Table of Contents Important Notice: Forward: Acronyms: Table of Contents: List of Charts i ii iv v ix Chapter 1 Background and Context for the EU-Japan Mutual Recognition Agreement (MRA) Introduction Objective of The Guide Background to the Development of the MRA MRAs in Force Referring Information 3 Chapter 2 Structure and Content of the MRA Explanation of EU-Japan MRA Structure and Product Sectors Covered by the MRA Content of the EU-Japan MRA Overall Framework Functions of Joint Committee and Joint Sectoral Committees 8 Chapter 3 Structure and Understanding the MRA Law Established in Japan What is the MRA Law? Purpose Definitions of Terminology The Content of the Law for Implementation of the Mutual Recognition between Japan and the European Community and the Republic of Singapore in relation to Conformity Assessment of Specified Equipment Contents of the Law Evaluations by Designated Accreditation Bodies Structure of the MRA Law Exceptions of Related Laws Stated in the MRA Law Exceptions under the Telecommunications Business Law Exceptions under the Radio Law Exceptions under the Electrical Appliance and Material Safety Law 15 Chapter 4 Japan s Standards and Conformity Assessment Infrastructure Overview Telecommunications Terminal Equipment and Radio Equipment & Electrical Products Conformity Assessment Infrastructure of EMC in Japan 21 v

7 4.2. GLP Monitoring Infrastructure in Japan Overview of GLP Monitoring Infrastructure in Japan GLP in Japan Good Manufacturing Practice (GMP) for Medicinal Products Designating Authority and the Related Laws for GMP in Japan Flow of Medicinal Approval, Manufacturing Control, Distribution and Post-Marketing System under the Pharmaceutical Affairs Law in Japan 24 Annex I Telecommunications Terminal Equipment and Radio Equipment The Applicable Laws, Regulations and Administrative Provision Stipulating Telecommunications Terminal Equipment and Radio Equipment in Japan The Applicable Laws, Regulations and Administrative Provisions Stipulating the Requirements and the Conformity Assessment Procedures Designating Authorities Implications for European Designating Authorities Designating Authorities in Japan The Applicable Laws, Regulations and Administrative Provisions Stipulating the Criteria for Designation of Conformity Assessment Bodies Japan s Conformity Assessment Infrastructure for Telecommunications Terminal Equipment and Radio Equipment Technical Regulation Conformity Certification System Stipulated in the Radio Law What is the Technical Regulations Conformity Certification System? Designated Certification Agencies Attested Private Inspectors, etc.: Simplification of Procedures Specified Radio Equipment Three Ways to Proceed the Technical Regulations Conformity Certification System Technical Conditions Compliance Approval System Stipulated in the Telecommunications Business Law What is the Technical Conditions Compliance Approval System? Designated Approval Agencies Recognized Approval Body Attested Examiners Amendment of MRA related Laws Contents of Amendment of MRA Related Laws Regarding Conformity Assessment System Effects on MRA 56 vi

8 Annex II Electrical Products Overview Electrical Appliance and Material Safety Law and other related Regulations for the MRA Classification of Electrical Appliances and Materials (Article No.2 of the Law) Outline from Pre-Market Measures, Marking Requirements to Post-Market Measures Concrete Procedure of Pre-Marketing and Marking Requirement Implication for European Designating Authority Implication for European Conformity Assessment Bodies Outline of Actual Approved CAB and Authorized CAB in Japan based on the Law Conformity Assessment Issues in Electrical Application and Material Safety Law and its Relationship with the MRA (Article 35 of the MRA Implementation Law and the Article 35 of Ordinance) Implication for European Manufacturers (Emphasizing Small and Medium Sized Companies) 79 Annex III Good Laboratory Practice (GLP) for Chemical Products Overview: GLP Related Laws and Regulations Implication for European GLP Monitoring Authorities Contact Points of European GLP Monitoring Authorities Contact Points with Japanese GLP Monitoring Authorities and Related Organizations Japanese GLP Inspection Authorities Implication for European manufacturers (Emphasizing Small and Medium Sized Companies) 97 Annex IV Good Manufacturing Practice (GMP) for Medicinal Products Overview Historical Background of GMP in Japan Outline of GMP in Japan Regulations for Manufacturing Control and Quality Control of Drugs and Quasi-drugs Provisions on Buildings and Facilities in Manufacturing Facilities Standards for the Quality Control of Imported Drugs and vii

9 Medical Devices (so called GMPI ) Implication for European Designating Authorities Organizational Structure in Japan Pharmaceutical Affairs Law and Related Laws Scope of GMP in Japan Implication for European Conformity Assessment Bodies Implication for European Manufacturers (Emphasizing Small and Medium Sized Companies) Contacts for Further Information List of European GMP Authorities Contacts for Further Information in Japan 109 viii

10 List of Charts [Chart 1] Concept and Structure of the Law for Implementation of the Mutual Recognition between Japan and the European Community and the Republic of Singapore in relation to Conformity Assessment of Special Equipment (Law No.111, 2001) 13 [Chart 2] Overall Framework of Japan s Conformity Assessment Infrastructure for Telecommunications Terminal Equipment and Radio Equipment 17 [Chart 3] Overall Framework of Japan s Conformity Assessment Infrastructure for Electrical Products 18 [Chart 4] Applicable Laws and Regulations for EMC Control System in Japan 21 [Chart 5] GLP Monitoring Authorities in Japan and their Fields of Competency 22 [Chart 6] Overview of Pharmaceutical Regulations under the Pharmaceutical Affairs Law in Japan 25 [Chart 7] the same as [Chart 2] 37 [Chart 8] Technical Regulations Conformity Certification System 39 [Chart 9] Flowchart of Technical Regulations Conformity Certification 40 [Chart 10] Flow of Technical Regulations Conformity Certification (Example of TELEC) 48 [Chart 11] Flow of Type Certification (Example of TELEC) 49 [Chart 12] Technical Conditions Compliance Approval System 50 [Chart 13] Flowchart of Technical Conditions Compliance Approval System Stipulated in the Telecommunications Business Law 53 [Chart 14] Flow of Technical Conditions Compliance Approval (Example of JATE) 54 [Chart 15] Flow of Type Approval (Example of JATE) 55 [Chart 16] Registered EC-CABs as Certification Bodies 57 [Chart 17] In the Case that European Exporters Use Japanese CABs 68 [Chart 18] In the Case that European Exporters Use Approved CAB in Europe 69 [Chart 19] In the Case of Other Electrical Appliances and Materials 69 [Chart 20] The Outline of Conformity Assessment Bodies Related Structure Based on the Electrical Appliance and Material Safety Law. 76 [Chart 21] the same as [Chart 3] 81 [Chart 22] Concept of Japanese GMP 102 [Chart 23] the same as [Chart 6] 105 [Chart 24] Procedures for Drug Approval and License 107 ix

11 Chapter 1 Background and Context for the EU-Japan Mutual Recognition Agreement (MRA) 1.1. Introduction The European Community (EC) and Japan concluded an agreement on mutual recognition (MRA) which entered into force on 1 January The MRA has the overriding objective of promoting trade in goods between the EU and Japan by facilitating market access. The agreement lays down the conditions under which the EU and Japan will accept certificates of conformity issued by the conformity assessment bodies (CAB) and test reports from confirmed test facilities of the other Party according to the requirements of the importing Party. This means that a European manufacturer can have its product tested and certified according to Japanese requirements by a CAB located in the EU. This would permit European manufacturers to turn to European conformity assessment bodies with whom they are familiar and thus avoid the burden, cost and time associated with having to seek out the service of a body in Japan. European CABs will in their turn be given the possibility of offering more comprehensive services. The EU-Japan MRA covers at the moment the following sectors: telecommunications terminal equipment and radio equipment, electrical products, Good Laboratory Practice (GLP) for chemicals and Good Manufacturing Practice (GMP) for medicinal products. The MRA does not call for harmonization of product or conformity assessment requirements between the EU and Japan. Each Party maintains its own legislation and regulatory requirements. The well functioning of the Agreement therefore requires that both sides have full knowledge and understanding of the other Party s legislative, regulatory and administrative requirements. In this respect, key players at the Member State level are the Designating Authorities, the conformity assessment bodies and of course manufacturing industry. It is also essential that CABs and industry are aware of the possibilities the MRA offers and have the necessary knowledge to exploit them. The European Commission services have therefore considered that it would be useful for Member States, European CABs and industry to have a guide with clear and practical information on the EU-Japan MRA Objective of The Guide The objectives of the EU-Japan MRA is to give benefits to European manufacturing industry in terms of more direct market access for their products in Japan with regard to conformity assessment procedures. In order for this objective to be realized in practical terms, it is essential that Member 1

12 States, CABs and manufacturing industry are aware of the possibilities the MRA offers and have the necessary information to take advantage of them. The main objective of the Guide to the EU-Japan MRA is therefore to give practical information to Designating Authorities, European industry and CABs on the operation of the Agreement. Thus, this Guide gives clear and simple explanations of the Agreement and the sectoral Annexes that are relevant to these key players. The detail is sufficiently practical and concrete that Member State authorities, European CABs and industry have a clear understanding of their rights and obligations under the MRA. The Guide, therefore, is for these key players under the EU-Japan MRA. For European Designating Authorities to have a clear understanding of what is required of them, in particular with regard to the Japanese requirements on CABs, in evaluating and monitoring the competence of CABs they are to designate or have designated. For European Conformity Assessment Bodies to have a clear understanding of what is required of them to obtain the status of CAB or confirmed testing facility under the MRA, the conformity assessment procedures they are to carry out and in relation to what type of product requirements. For European manufacturers to have a clear understanding of whether their products are covered by the MRA and if so what possibilities the MRA offers and what requirements the products would have to comply with Background to the Development of the MRA MRAs in Force The EC regards mutual recognition as a key instrument for promoting international trade. For regulated products, this is achieved so far through the conclusion of Mutual Recognition Agreements (MRAs) among with the EU Member States. Now Mutual Recognition Agreements are established between the Community and the Governments of third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment. Seven Mutual Recognition Agreements on conformity assessment between the European Community and third countries have so far entered into force: with the United States (1/12/98), with Canada (1/11/98), with Australia and New Zealand (1/1/99), with Israel (1/5/00), with Japan (1/1/02) and with Switzerland (1/6/02.). 2

13 Referring Information Full text of related documents may be obtained at the locations indicated below: a) Guide to the Implementation of Directives Based on New Approach and Global Approach; b) Implementing Policy for External Trade in the Fields of Standards and Conformity Assessment: A Tool Box of Instruments; c) Community External Trade Policy in the Field of Standards and Conformity Assessment, Communication of the Commission; Full texts of MRA Agreements are as follows; a) EU-Australia MRA Text; mdoc=21998a0817(01)&model=guichett b) EU-New Zealand MRA Text; N&numdoc=21998A0817(02)&model=guichett c) EU-US MRA Text; N&numdoc=21999A0204(01)&model=guichett d) EU-Canada MRA Text; N&numdoc=21998A1016(01)&model=guichett e) EU-Israel MRA Text; f) EU-Japan MRA Text; mdoc=22001a1029(01)&model=guichett g) EU-Switzerland MRA Text; N&numdoc=22002A0430(05)&model=guichett 3

14 Full text of MRA Guides and other information are as follows: a) Australia and New Zealand MRA Guide; b) Canada MRA Guide; c) USA MRA Guide; d) Procedure for Designation of Conformity Assessment Bodies (CABs) Under Mutual Recognition Agreement (MRAs) with Non-Member Countries; 4

15 Chapter 2 Structure and Content of the MRA 2.1. Explanation of the EU-Japan MRA A Mutual Recognition Agreement is a binding agreement between countries under which one country recognizes the Conformity Assessment procedures of another country to that other country s rule and regulations, as being of equal value to the processes in the first country. Therefore, under the Mutual Recognition Agreement between the European Community and Japan, EC products exported to Japan, which have been assessed in Europe, can access the Japanese market without any further conformity assessment. The MRA extends equal rights to Japan by allowing conformity assessment of exported products to be undertaken in Japan, rather than having to be carried out in Europe. If European industries and CABs are to take advantage of the MRA with Japan, they will need to be aware of the regulatory and conformity assessment requirements they need to meet. In recognizing that different legislative and regulatory requirements apply between the MRA partners, the Agreement does not create a direct equivalence between European and Japanese regulations. Rather the MRA allows for mutual recognition of test results and other conformity assessment documentation, including certification. The Agreement is the first bilateral agreement on mutual recognition for Japan. It also symbolizes the smooth progress of the Decade of Japan-Europe Cooperation which started in The Action Plan for EU-Japan Cooperation, adopted at the EU-Japan summit in December 2001, states that the EU and Japan will start implementing the Agreement with the expectation that mutual trade will be promoted. Full text of Japan-EU framework and overview of their relations are as follows; a) EU-Japan Global Partnership for 21 st Century b) An Action Plan for EU-Japan Cooperation Structure and Product Sectors Covered by the MRA The MRA with Japan covers following four fields; Telecommunications terminal equipment and Radio equipment Electrical products Good Laboratory Practice (GLP) for chemical products 5

16 Good Manufacturing Practice (GMP) for medicinal products The MRA is divided into an overall framework agreement and sectoral Annexes. The overall framework is consisting with 15 articles. The each sectoral Annex is specific to each product sector and is divided into two parts; Part A and Part B. Part A gives the scope and coverage for each sector and Part B shows the list of regulations that each party applies Content of the EU-Japan MRA Overall Framework Article 1: Definitions This article specifies the definitions of terminology used in the Agreement. a) Conformity assessment procedure b) Conformity assessment body c) Designation d) Designating Authority e) Criteria for designation f) Confirmation of the compliance of manufacturing facilities or test facilities g) Competent Authority h) Criteria for confirmation i) Verification Article 2: a) Acceptance of the results of conformity assessment procedures conducted by the registered conformity assessment bodies of the other Party. b) Acceptance of the confirmation of facilities conducted by the Competent Authorities of the other Party. c) Acceptance of the data generated by confirmed facilities of the other Party. Article 3: Criteria for Sectoral Annexes a) Sectoral Annexes consist of Part A and Part B. b) Part A of Sectoral Annex includes scope and coverage. c) Part B sets out the applicable laws, regulations and administrative provisions of each Party. Article 4: Rights and Obligations for Designating Authorities and Competent Authorities Article 5: Audits, Inspections or Monitoring of the registered conformity assessment bodies and the confirmed facilities by each Party 6

17 Article 6: Suspension and/or lifting of the suspension of a registered conformity assessment bodies (CABs) Article 7: Rights of Joint Committee Contestation of a registered conformity assessment body shall be notified to the Joint Committee. The Joint Committee decides to conduct a joint verification with the Designating Authority and discuss the result if the registered conformity assessment body shall be suspended. Article 8: Setting up of a Joint Committee a) A Joint Committee is established for the effective functioning of this Agreement. b) A Joint Committee shall take decisions and adopt recommendations by consensus. c) A Joint Committee considers the followings; - registration, suspension, lifting and termination of conformity assessment bodies - establishment and publication of lists of the registered conformity assessment bodies and the confirmed facilities - information exchange referred to this Agreement - appointment of experts from each Party for the joint verification Article 9: Procedure of the registration of a conformity assessment body a) Each Party shall make a proposal that a CAB of one Party designated by its Designating Authority be registered under this Agreement, to the other Party and the Joint Committee. b) The other party shall consider whether the proposed CAB complies with the criteria for designation within 90 days. The Joint Committee shall take a decision whether to register the proposed CAB within 90 days. c) If the Joint Committee cannot decide to register the proposed CAB, the Joint Committee may decide to conduct a joint verification. d) List of necessary information should be provided for registration of a CAB. e) Procedure for withdrawals of the designation of a registered conformity assessment body. f) Procedure for termination of the registration of its conformity assessment body. Article 10: No limitation for protecting health, safety or the environment and for visiting manufacturing facilities a) Nothing in this Agreement shall be construed to limit the authority of a Party to take measures it considers appropriate, for protecting health, safety or the environment or prevention of deceptive practices. b) The Competent Authority of a Party may visit manufacturing facilities of the other Party if it is necessary. c) The definition of the emergency and the modalities of such visit will be decided by the Joint Committee. 7

18 Article 11: Limits set to this Agreement a) Nothing in this Agreement shall entail mutual acceptance of the standards or technical regulations of the Parties nor an obligation upon a Party to accept the result of the conformity assessment procedures of any third country. b) Nothing in this Agreement shall affect the rights and obligations that either Party has as a Member to the WTO Agreement, including the WTO Agreement on Technical Barriers to Trade and the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights. Article 12: Application of this Agreement This Agreement applies to the territory of Japan and to the territories of European Community. Article 13: Disclosure of information Neither Party shall disclose any information obtained under this Agreement as confidential, unless otherwise required under the laws or regulations of each Party. Article 14: The Date of this Agreement into force This Agreement shall enter into force on the first day of the second month following the date on which the Parties exchange diplomatic notes information each other. Article 15: About the Sectoral Annexes to this Agreement a) The Sectoral Annexes to this Agreement are an integral part of this Agreement. b) In case of conflict between the provisions of Part A of a Sectoral Annex and Articles 1 to 15 of this Agreement, the provisions of Part A of the Sectoral Annex shall prevail Functions of Joint Committee and Joint Sectoral Committees As referred to Article 8 of the EU-Japan MRA Agreement, a Joint Committee which is made up of representatives of both Parties are established on the date of the entry into force of this Agreement, as a body responsible for the effective functioning of this Agreement. Related information regarding Joint Committee Meetings and Sub-Joint Committee Meeting may be obtained at the locations listed below. a) Full text of the Rules of Procedure for the Joint Committee Meetings b) About second Joint Committee Meeting c) Decisions taken by the Joint Committee d) Rules of Procedure for the Sub-committee under the Sectoral Annex on Good Manufacturing Practice (GMP) for Medicinal Products 8

19 Chapter 3 Structure and Understanding the MRA Law Established in Japan 3.1. What is the MRA Law? The Government of Japan established the Law for Implementation of the Mutual Recognition between Japan and the European Community and the Republic of Singapore in Relation to Conformity Assessment of Specified Equipment, (so called MRA Law), (Law No.111, 2001). Two of the four sectors covered in this EU-Japan MRA and the Japan-Singapore Economic Partnership Agreement (JSEPA) are specifically covered by the MRA Law: telecommunications terminal equipment and radio equipment and electrical products Purpose The purpose of this Law is to facilitate the import and export of specified equipment between Japan and the European Community and the Republic of Singapore by setting forth the necessary matters for the conduct of overseas conformity assessment business, making provision for exceptions under the Telecommunications Business Law (Law No. 86, 1984), Radio Law (Law No. 131, 1950) and Electrical Appliance and Material Safety Law (Law No. 234, 1961), and taking other steps to ensure the proper implementation of the Agreement on Mutual Recognition between Japan and the European Community Definitions of Terminology a) Specified Equipment: Specified Equipment is composed of specified export equipment and specified import equipment. b) Specified Export Equipment: Specified export equipment used in this Law means the equipment and products set forth below; The telecommunications terminal equipment and radio equipment stipulated in the laws, regulations and administrative provisions stated in the Sectoral Annex on Telecommunications terminal equipment and Radio equipment. Electrical products stipulated in the laws, regulations and administrative provisions stated in the Sectoral Annex on Electrical Products. c) Specified Import Equipment: Specified import equipment used in this Law means the equipment and products set forth below; Terminal equipment as stipulated in Article 50 paragraph (1) of the Telecommunications Business Law and the same shall apply in Article 31. 9

20 Specified radio equipment as stipulated in Article 38-2 paragraph (1) of the Radio Law and the same shall apply in Article 33, paragraph (1) and (3). Specified electrical appliances and materials as stipulated in Article 2 paragraph (2) of the Electrical Appliance and Material Safety Law and the same shall apply in Article 35. d) Overseas conformity assessment business: Overseas conformity assessment business used in this Law means the business of conformity assessment of the specified export equipment set forth in each of technical requirements stipulated in the applicable laws and regulations. e) Designated Accreditation Bodies: Designated Accreditation Bodies are designated by the competent minister (such as that of the Ministry of Public Management, Home Affairs, Posts and Telecommunications and the Ministry of Economy, Trade and Industry). They are to conduct evaluations of the management system of overseas conformity assessment businesses on be half of the competent minister. f) Registered Foreign Conformity Assessment Body: Registered foreign conformity assessment body is a conformity assessment body of the European Community which has been designated and registered by a Designating Authority of the European Community. g) Competent Ministers: The competent ministers in this Law are the Minister of Public Management, Home Affairs, Posts and Telecommunications and the Minister of Economy, Trade and Industry The Content of the Law for Implementation of the Mutual Recognition between Japan and the European Community and the Republic of Singapore in relation to Conformity Assessment of Specified Equipment Contents of the Law Chapter I General Provisions (Article 1-2) Article 1: Purpose of this Law Article 2: Definitions Chapter II Designation of Conformity Assessment Bodies (Article 3-13) Article 3: Designation of overseas conformity assessment business Article 4: Disqualification Criteria Article 5: Criteria for Designation of overseas conformity assessment business Article 6: Renewal of Designation 10

21 Article 7: Changes of Designated Conformity Assessment Bodies, etc. Article 8: Suspension and Discontinuation of Business Article 9: Book Keeping and Records Relating to Business Article 10: Orders Issued to Approved Conformity Assessment Bodies Article 11: Issuance of Public Notice of Registration, etc. Article 12: Issuance of Certificates of conformity with a special mark related to the designated conformity assessment business. Article 13: Withdrawal of Designation Chapter III Designated Accreditation Bodies (Article 14-28) Article 14: Evaluations by Designated Accreditation Bodies Article 15: Designation Article 16: Disqualification Criteria Article 17: Criteria for Designation of Accreditation Bodies Article 18: Issuance of Public Notice of Designation of Accreditation Bodies Article 19: Renewal of Designation Article 20: Confidentiality Article 21: Duty to Evaluation Article 22: Appointment and Dismissal of Officers Article 23: Rules and Procedures for Evaluation Article 24 Book Keeping and Records Article 25: Supervisory Orders Article 26: Suspension and Discontinuation of Activities Article 27: Revocation of Designation Article 28: Performance of Evaluation Activities by Competent Ministers Chapter IV Exceptions under the Telecommunications Business Law, etc. Section 1: Registered Foreign Conformity Assessment Bodies (Article 29-30) Article 29: Definitions of registered foreign conformity assessment body Article 30: Issuance of Public Notice of Registration Section 2: Exceptions under the Telecommunications Business Law (Article 31-32) Section 3: Exceptions under the Radio Law (Article 33-34) Section 4: Exceptions under the Electrical Appliance and Material Safety Law (Article 35) Chapter V Miscellaneous Provisions (Article 36-44) Article 36: Performance of Evaluation Activities by NITE Article 37: On-site Inspection by the competent minister Article 38: Joint verification conducted by the Joint Committee Article 39: Issuance of Orders to the NITE Article 40: Fees Article 41: Demand for Examination Article 42: Transitional Measures 11

22 Article 43: Consultation with the Minister of Economy, Trade and Industry Article 44: Competent Ministers Chapter VI Penal Provisions (Article 45-52) Supplementary Provisions (Law No. 111, 2001) (Article* 1-3) Article* 1: Date of Enforcement Article*2: Preparatory Actions Article*3: Partial Amendment of the National Institute of Technology and Evaluation Laws Supplementary Provisions (Law No. 31, 2002) (Article* 1-3 as shown above) Evaluations by Designated Accreditation Bodies The competent minister may commission a person/organization designated by him, so called designated accreditation body to conduct evaluations in whole or in part of the course of designation of the applicant conformity assessment body who intends to engage in overseas conformity assessment business. Where a designated accreditation body conducts an evaluation in respect of an application to obtain an approval of a CAB, it must report to the competent minister the results of the evaluation without delay as stipulated by the applicable ministerial ordinance. 12

23 b e t w e e n J a C p o a n n f o a r n m d i t t y h e A s E s u e r s o s p m e a e n n t C o o f m S m p e u c n i f i t i e y d a n E d q u t h i p e m R e e n p t u ( L b a l i c w o N f o S. i 1 n 1 g 1 a, p 2 o 0 r 0 e 1 i ) n r e l a t i o n t o J A P A N E C / S i n g a p o r e * D e T s h i g e n C a t o i n m g p A e u t e t h n o t r M i t i i e n s i s it n e r J s a o p f a n D e s i g n a t i n g A u t h o r i t i e s i n E C M P H P T a n d / o r M E T I ( S i n g a p o r e ) A r t i c l e 3 9 : O r d e r s da e r t s i c i g l e n a 3 t : i o P n r o o c f e C d A u r B e f o r TN e ai T c t i h E o n * n o* a : l l o I g n y s t a i t n u d t e o f J o i n t C o m m i t t e e E v a l u a t i o n A r t i c l e 1 1 & 3 0 : P u b l i c N o t i c e A r t i c l e 2 9 : D e f i n i t i o n s A r t i c l e 1 4 : R e p o r t A r t i c l e , 1 9 : D e s i g n a t e A r t i c l e 3 7 : I O n s n p - e s i c t e t i o n A rr r tt t ii i c ll l e :: : O W nr i d t - h se d i r t s r e a w I n a s l p a e n c d t i o S n u s p e n s i o n R e g i s t ( e S r ei n d g a C p A o B r e s ) i n E C id n e J s a i g p n a a n t e d A c c r e d i t a t i o n B o d i e s A r t i c l e 3 6 : E v a l u a t i o n A r t i c l e 3 7 : O n - s i t e i n s p e c t i o n A r t i c l e 1 4 : E v a l u a t i o n R e g i s t e r e d C A B s i n J a p a n A r t i c l e 3 1 0, 8 7,, 82, , , 3 6 A r t i c l e 1 2 : I s s u a n c e o f C e r t i f i c a t e M a n u f a c t u r e r s i n J a p a n M a n u ( S f a i nc t g u a r p e or s r e i n ) E C I s s u a n c e o f P u b l i c N o t i c e E C M a r k e t * A A r r t t i i c c l l e e : 8 O : r D d e e r s s i g n a t i o n J a p a n e s e M a r k e t A RT e r a t l i d e c ic l o e o L m 3 a 1 m w - u a 3 n n 5 i c d : a E E t i x o l e c n ce s t p r B it c i o u a n s l i s A n e u p s n p s d l i a e L n r a c t w h e, e a n d ( S i n g a p o r e ) A A r r t t i i c c l l e e : : OE W v n i a t - h s l u d i t a er a t i i w o n n a s p l b a e y n c t t d h i o e s n u c s o p m e p n e s t i o e n t m i n i s t e r s M a t e r i a l S a f e t y L a w * * N A r I t T i c E l e 3 r e 8 : l a J t o e i n d t v m e r a i f i t c t a e t r i o s n ( p r i n t e d w i t h b l u e c o l o r ) a r e o n l y c o v e r e d b y M E T I. M PE HT I P : T M : i n M i s i n t r i sy t ro y f o E f c P o n u o b m l i c y M, T a r n a a d g e e a m n e d n I t n, d H u o s m t r e y A f f a i r s, P o s t s a n d T e l e c o m m u n i c a t i o n s R S o e v u i r s c i e o : n J a a n p d a M n - o E d U i f i M c a R t i A o n G : u b y i d M e T B A o o J k a, p J a a n p a C n o. M, L a t c d h. i n e r y C e n t e r f o r T r a d e a n d I n v e s t m e n t, p a g e Structure of the MRA Law [Chart 1] 13

24 3.3. Exceptions of Related Laws Stated in the MRA Law Exceptions under the Telecommunications Business Law For the purpose of application of the provisions of Article 51 paragraph (1) of the Telecommunications Business Law, the following terminal equipment shall be regarded as terminal equipment for which compliance with relevant technical conditions has been approved as specified in Article 50 paragraph (1) of the same law: - Terminal equipment approved as complying with the technical conditions set forth in the Ministry of Public Management, Home Affairs, Posts Telecommunications ordinance specified in Article 49 paragraph (1) of the Telecommunications Business Law by a registered foreign conformity assessment body to which the mark stipulated in the Ministry of Public Management, Home Affairs, Posts and Telecommunications ordinance has been affixed by the registered foreign conformity assessment body. - Terminal equipment based on a type where such type has been certified as complying with the technical conditions set forth in the Ministry of Public Management, Home Affairs, Posts and Telecommunications ordinance specified in Article 49 paragraph (1) of the Telecommunications Business Law by a registered foreign conformity assessment body in response to an application by a foreign dealer specified in Article 50-4 paragraph (2) of the same law to which the mark stipulated in the Ministry of Public Management, Home Affairs, Posts and Telecommunications ordinance has been affixed by the registered foreign conformity assessment body. For the purpose of application of the provisions of Article 50 paragraph (3) and Article 50-4 paragraph (4) of the Telecommunications Business Law, a registered foreign conformity assessment body shall be regarded as a person who has obtained the approval stipulated in Article 50-3 paragraph (1) of the same law Exceptions under the Radio Law For the purpose of application of the provisions of Article 4, Article 13 paragraph (2), Article 15 and Article 27-2, the following specified radio equipment shall be regarded as specified radio equipment for which conformity with technical regulations has been certified as specified in Article 38-2 paragraph (1) of the same law. - Specified radio equipment certified as complying with the technical regulations set forth in Chapter III of the Radio Law by a registered foreign conformity assessment body to which the mark stipulated in the Ministry of Public Management, Home Affairs, Posts and Telecommunications ordinance has been affixed by the registered foreign conformity assessment body. - Specified radio equipment based on a construction type where such construction type has 14

25 been certified as complying with the technical regulations set forth in Chapter III of the Radio Law by a registered foreign conformity assessment body in response to an application by a foreign dealer specified in Article paragraph (2) of the same law to which the mark stipulated in the Ministry of Public Management, Home Affairs, Posts and Telecommunications ordinance has been affixed by the registered foreign conformity assessment body. For the purpose of application of the provisions of Article 38-2 paragraph (5) and Article paragraph (4) of the Radio Law, a registered foreign conformity assessment body shall be regarded as a person who has obtained the approval stipulated in Article 24-9 paragraph (1) of the same law Exceptions under the Electrical Appliance and Material Safety Law Where a Reporting Supplier specified in Article 3 of the Electrical Appliance and Material Safety Law keeps any of the certificates described under any of the following items before sale of the Specified Electrical Appliances and Materials relating to manufacture or import thereby, the Reporting Supplier shall be treated as having undergone conformity assessment pursuant to the same paragraph, obtained a certificate pursuant to the same paragraph, and keeping such certificate pursuant to the provisions of the main clause of Article 9 paragraph (1) of the same law. - Certificate issued to the Reporting Supplier in respect of the Specified Electrical Appliances and Materials by a registered foreign conformity assessment body, provided that it certifies conformity in accordance with the technical requirements stipulated in Article 8 paragraph (1) of the same law and/or the requirements for testing facilities and other matters stipulated in the ordinance of the Ministry of Economy, Trade and Industry noted in Article 9 paragraph (2) of the same law in any of the items in Article 9 paragraph (1) of the same law. - An International Certificate obtained in respect of a Specified Electrical Appliance and Material of the same type as the Specified Electrical Appliance and Material, provided that the period stipulated in the provision to the same paragraph has not yet passed from the date of issue of the certificate. 15

26 Full text of each law may be obtained below. a) Law for Implementation of the Mutual Recognition between Japan and the European Community and the Republic of Singapore in relation to Conformity Assessment of Specified Equipment (Law No.111, 2001) b) Telecommunications Business Law (Law No.86 of December 25, 1984) c) Radio Law (Law No. 131 of May 2, 1950) d) Electrical Appliance and Material Safety Law (Law No. 234 of 1961) 16

27 Chapter 4 Japan s Standards and Conformity Assessment Infrastructure 4.1. Overview [Chart 2] 17

28 [Chart 3] 18

29 Telecommunications Terminal Equipment and Radio Equipment & Electrical Products To place the telecommunications terminal equipment and radio equipment and the electrical products in Japanese market, those products should conform to Telecommunications Business Law, Radio Law and Electrical Appliance and Material Safety Law and related cabinet order, ordinances and other regulations. Conformity assessment infrastructure is composed by designating authorities, designated accreditation bodies and CABs in Japan. In case of the telecommunications terminal equipment and radio equipment and the electric products, designating authorities are the Ministry of Public Management, Home Affairs, Posts and Telecommunications (MPHPT) and the Ministry of Economy, Trade and Industry (METI). For the electric products sector, there are three accreditation bodies in Japan: 1) International Accreditation Japan (IA Japan), 2) The Japan Accreditation Board for Conformity Assessment (JAB) and 3) Voluntary EMC Laboratory Accreditation Center, Inc. Each accreditation body has their certain laboratory accreditation programs listed as below. Please take note that although there is no registered laboratory under EU-Japan MRA as of July 2003, however, the chart describes the actual existing CABs in Japan for the reference to European exporters. (1) International Accreditation Japan (IA Japan) The IA Japan runs several accreditation programs. The number in parenthesis shows the number of laboratories accredited by each system. They are: 1 Japan Calibration Service System (JCSS) to accredit calibration laboratories (110) 2 Japan National Laboratory Accreditation (JNLA) which accredit testing laboratories (mainly to demonstrate the conformance to Japan Industrial Standards (JIS) (90) 3 Testing laboratories accreditation for JIS product certificate and 4 Accreditation System of National Institute of Technology and Evaluation (AS NITE) to accredit a) certified reference material b) National Metrology Institute c) calibration laboratories other than JCSS d) testing laboratories other than JNLA. (However, AS NITE is a new program and so far there is no laboratories accredited for electric products and telecommunication equipment. AS NITE accredited 12 testing laboratories in the field of textile, metal and chemical as of Nov ) (2) The Japan Accreditation Board for Conformity Assessment (JAB) 19

30 JAB accredits various fields such as, 1 calibration laboratories (20) 2 testing laboratories (120) 3 QS9000 series certification bodies (6) 4 ISO9000 series certification bodies (44) 5 ISO14000 certification bodies (37) JAB works as a designated accreditation body for Japan-EU MRA as well. (3) Voluntary EMC Laboratory Accreditation Center, Inc. (VLAC) VLAC works for accreditation of EMC testing laboratories (16) and works as designated accreditation body for Japan-EU MRA. (4) CABs based on Telecommunications Business Law Four (4) Designated Approval Agencies work as certification body for Telecommunications Business Law. Sixteen (16) Attested Examiners and four (4) Attested Foreign Examiners work as testing bodies for the law. The numbers are as of August, (5) CABs based on Radio Law Four (4) Designated Certification Agencies work as certification body for the Radio Law. Fifty seven (57) Attested Private Inspectors and five (5) Attested Private Foreign Inspectors work as testing body for the Law. The numbers are as of August 11, (6) CABs based on Electrical Appliance and Material Safety Law Based on Electrical Appliance and Material Safety Law, there are six (6) authorized laboratories for electric products safety testing, namely Japan Electrical Safety & Environment (JET) Japan Quality Assurance Organization (JQA) Japan Electric Cable Technology Center, Inc. (JECTEC) TÜV Rheinland Japan Ltd. Cosmos Co., Ltd. UL APEX Co., Ltd. Other than above six authorized assessment bodies, there are four (4) approved overseas conformity assessment bodies for electric products safety testing based on the Electric Appliance and Material Safety Law. Underwriters Laboratories Inc. Illinois, U.S.A UL International DEMCO A/S Herlev, Denmark Intertek Testing Services Hong Kong Ltd. TÜV Rheinland Product Safety GmbH The details of Japan s conformity assessment structure will be explained in Annex. 20

31 P r o d u c t C a t e g o r y E x a m p l e o f P r o d u c t s I n d V u s o t rl u i a n l t a S r t y a n ( d 2 a ) r d s T B L a w E A M S L a w ( 1 ) P A L a w V o l u n t a r y A p p l i c a b l e L a w s I T E q u i p m e n t C o m p u t e r X X T T E CA o n m a l po ug t T e r e l r e e p l a h t o e d n e p e r i p h e r a l s X X C F a o c r s d i l m e s i s l e P h o n e X X M o b i l e P h o n e X X MP B o X d e m X X PR H a d S i o X X E l e c t r i c a l C o p i e r s X X A p p l i a n c e EF u l e l c o t r r e o s n c i e c n W t L i i r g e h s t s X X X X M i c r o w a v e O v e n X X RT r e a f n r i s g f e o r r a m t o e r r s s X X TV V C s R s X X O t h e r s X X E M q e u d i i p c m a l e n t X M - R R I a E y q G u e i n p e m r ea nt o t r X X ( T 3 B ) L a w : T e l e c o m m O u n t h i c e a r s t i o n s B u s i n e s s L a w X X E A M S : E l e c t r c i a l A p p l i a n c e a n d M a t e r i a l S a f e t y L a w PV A o l u L n a t w a r : y P m h a e r a m n a s c e e a u c t h i c i a n l d A u f s f t a r i i a r s l a L s a s w o c i a t i o n ' s s t a n d a r d s ( 1 ) E M C e m i s s i o n r e g a r d i n g E M A S L a w a r e b a s e d o n C I S P R 1 3, 1 4 & 2 2 F F o o r r s o p t h e e c r i f e i e l e d c e t r l i e c c a t l r i a c p a p l l a i p a n p c l i e a s n ac ne s d a m n ad t e m r i a a t l e s r i ( a 3 l 4 s 0 ( 1 i 1 t e 2 m i s t e ) m = s S ) : e S l f e d l f e c d l e a c r l a a t r i a o t n i o n + t h i r d p a r t y c o n f o r m i t y a s s e s s m e n t ( 2 ) E M I r e g u l a t i o n r e g a r d i n g I T e q u i p m e n t i s C I S P R Conformity Assessment Infrastructure of EMC in Japan There are four accredited EMC testing laboratories by JAB and 16 accredited laboratories by VLAC. Other than those accredited laboratories, there are thousands of voluntary EMC testing laboratories within industries. The following shows EMC testing requirements in Japan. [Chart 4] Applicable Laws and Regulations for EMC Control System in Japan 21

32 T h e M i n i s t r y o f H e a l t h, L a b o u r a n d W e l f a r e - N e w S u b s t a n c e s a n d D - e P s h i g a n r a m t e a d c e S u u t i b c s a t l a s n c e s ( t o x i c o l o g i c a l t e s t s ) - S u b s t a n c e s c o n t r o l l e d f o r t h e p r e v e n t i o n o f h e a l t h h a z a r d o f w o r k e r s ( h t t p : / / w w w. m h l w. g o. j p / e n g l i s h / i n d e x. h t m l ) T h e M i n i s t r y o f A g r i c u l t u r e, F o r e s t r y a n d F i s h e r i e s - V e t e r i n a r y C h e m i c a l s ( h t t p : / - / w A w g r w i c. m u l t a u f r f a. g l o C. j h p e / e m i n i c d a e l x s. h t m l ) T h e M i n i s t r y o f E c o n o m y, T r a d e a n d I n d u s t r y - N e w S u b t e s s t a t i n n g c e, s s t a u n d d i e s D e o s n i g b n e a h t a e v d i o S r u i n b s w t a a n t e c r e, s s o ( p i l h a y n s d i c a a l i r c ) h e m i c a l ( h t t p : / / w w w. m e t i. g o. j p / e n g l i s h / i n d e x. h t m l ) T h e M i n i s t r y o f E n v i r o n m e n t - E c o t o x i c i t y t e s t i n g ( v o l u n t a r y ) a n d o t h e r e n v i r o n m e n t a l i s s u e s ( h t t p : / / w w w : e n v. g o. j p / e n / i n d e x. h t m l ) L a b o r a t o r i e s S t u d i e s 4.2. GLP Monitoring Infrastructure in Japan Overview of GLP Monitoring Infrastructure in Japan. [Chart 5] GLP in Japan GLP relates to various different fields in chemical products. Depending on the nature of products, different designating authorities have responsibilities for GLP compliance. The Authorities in charge are: the Ministry of Health, Labour and Welfare, the Ministry of Agriculture, Forestry and Fisheries, the Ministry of Economic, Trade ad Industry, the Ministry of Environment. The contents of GLP application vary Ministry by Ministry and typical example of required contents to the application will be found in the Annex Good Manufacturing Practice (GMP) for Medicinal Products Designating Authority and the Related Laws for GMP in Japan Ministry of Health, Labour and Welfare, Pharmaceutical and Food Safety Bureau, Compliance and Narcotics Division is the Japan s Designating Authority for GMP in Japan. The functions of Compliance and Narcotics Division are as follows: Control of quality defects, falsely labeled products Guidance an supervision related to advertising Testing and batch release control GMP compliance Matters related to pharmaceutical inspectors Japan s pharmaceutical industry is administered under the Pharmaceutical Affairs Law and related laws and the Pharmaceutical Affairs Law plays a main role of it. The scheme of Good Manufacturing Practice (GMP) in Japan comprises two ministerial ordinances which are based on Article 13 of the Pharmaceutical Affairs Law. One is Regulations for Manufacturing Control and Quality Control of Drugs and Quasi-drugs stipulating duties of drug manufacturers, and the other is Regulations for Buildings and Facilities for Pharmacies etc.. These regulations are stipulated as the conditions for a manufacturing license of drugs. In addition to these ordinances, GMP requirements are set under Pharmaceutical Affairs Law. The followings are other related laws: a) The Pharmaceutical Affairs Law 22

33 b) Pharmacists Law c) The Organization for Pharmaceutical Safety and Research Law d) Poisonous and Deleterious Substances Control Law e) Bleeding and Blood Donor Supply Service Control Law f) Narcotics and Psychotropics Control Law g) Cannabis Control Law h) Opium Law i) Stimulants Control Law Flow of Medicinal Approval, Manufacturing Control, Distribution and Post-Marketing System under the Pharmaceutical Affairs Law in Japan 23

34 [Chart 6] The chart shown in explains the procedure of medicinal approval, manufacturing control, distribution and post-marketing system under the Pharmaceutical Affairs Law in Japan. GMP is prerequisite of all the procedure, such as approval application, manufacturing, distribution and post-marketing. In Japan, GMP is controlled by Ministry of Health, Labour and Welfare with the communication of 7 regional bureau of health and welfare (Hokkaido/ Tohoku/ Kanto/ Toukai/ Kinki/ Chu-Shikoku and Kyushu) and 47 prefecture governments. GMP in Japan is under the control of pharmaceutical inspectors, who make on-the-spot inspections of drug manufacturers (approximately 2,300), medical device manufacturers (2,700), quasi-drug and cosmetic manufacturers(2,800), drug importers (800), medical device importers (1,200), quasi-drug and cosmetic importers (1,100), pharmacies (44,100) and drug sellers (66,200). Their main duties are 1) to inspect GMP compliance 2) to control unapproved, un-licensed and defective drugs with unlawful labeling 3) to control false or exaggerated advertisement. As an example, procedure of medicinal product s approval and license of prescription drugs are discussed in the Annex. To obtain approval and license of prescription drugs, the following data is needed (concrete application detail is described in Annex). A B C D E F G Data on origin, details of discovery, use in foreign countries etc. Data on physical and chemical properties, specification, testing methods etc. Data on stability Data on acute toxicity, subacute toxicity, chronic toxicity, teratogenicity and other toxicities Data on pharmacological action Data on absorption, distribution, metabolism and excretion Data on results of clinical trials In principle, an application will be forwarded to the Pharmaceutical and Medical Devices Evaluation Center (PMDEC) through prefecture governments. The application received by PMDEC is subject to the compliance review of the Organization for Pharmaceutical Safety and Research Center (OPSR) and to the review of PMDEC, and then decided whether or not to seek the opinion of the Pharmaceutical Affairs and Food Sanitation Council (PAFSC). The Minister may, where necessary, seek the opinion of PAFSC. PAFSC, an advisory body of the Minister, consists of members specialized in medicine, pharmacy and in other related fields who belong to the national research institutes, universities etc. Approval application are reviewed on the basis of data submitted by the applicant. Fundamental guidelines for applicants to make up a set of data and studies which 24

35 is necessary to be attached to the application is as follows; 1) Guidelines for toxicity studies required for applications for approval to manufacture/import drugs was made public in 1984 to provide a standard for toxicity studies, and was amended in 1989, 1993 and In order to assure the quality and reliability of data, tests and studies must be concluded by competent personnel using appropriate facilities and equipment and institutions engaged in the studies must be properly operated. As to toxicity studies, Good Laboratory Practice (GLP) has been performed under the administrative guidance since 1982, which notification was published in 1997, providing standards for the organization and operation of testing institutions, as well as for building and facilities. In addition, Good Clinical Practice (GCP) has been performed under the administrative guidance since 1992, which notification was published in 1997 and enforced in April Fundamental data and studies to be attached to the application have to demonstrate the quality and reliability of data and studies based on GLP, GMP and GCP. 25

36 Annex I: Telecommunications Terminal Equipment and Radio Equipment 1.1. The Applicable Laws, Regulations and Administrative Provision Stipulating Telecommunications Terminal Equipment and Radio Equipment in Japan (1) Telecommunications Business Law (Law No. 86, 1984) and amendments thereto The purpose of this Law is, considering the public nature of telecommunications business, by ensuring the proper and reasonable operation of such business as well as promoting fair competition thereof, to secure the consistent provision of telecommunications service, to protect the interests of its users, and thereby to ensure both the sound development of telecommunications and the convenience of people, and to promote the public welfare. (2) Ordinance concerning Technical Conditions Compliance Approval and Certification of the Type for Terminal Equipment (Ordinance of the Ministry of Posts and Telecommunications No. 14, 1999) and amendments thereto The purpose of this Ministerial Ordinance shall be to stipulate matters concerning technical conditions compliance approval for terminal equipment and the certification under Article 50 paragraph (1), Article 50-4 paragraph (1), Article 72-2 paragraph (1) and Article 72-3 paragraph (6) of the Telecommunications Business Law. (3) Radio Law (Law No. 131, 1950) and amendments thereto The purpose of this Law is to promote public welfare by ensuring the equitable and efficient utilization of radio waves. (4) Ordinance concerning Technical Regulations Conformity Certification of Specified Radio Equipment (Ordinance of the Ministry of Posts and Telecommunications No. 37, 1981) and amendments thereto The purpose of this Ordinance is to define the technical requirements to be enforced by Law and its provisions, exclusive of those specified elsewhere, of Certification of Conformity of Specified Radio Equipment with the Technical Regulations of the Ordinance The Applicable Laws, Regulations and Administrative Provisions Stipulating the Requirements and the Conformity Assessment Procedures 26

37 (1) Telecommunications Business Law (Law No. 86, 1984) and amendments thereto (Explained in the previous section.) (2) Ordinance concerning Terminal Facilities etc. (Ordinance of the Ministry of Posts and Telecommunications No. 31, 1985) and amendments thereto The objectives of this ordinance are to provide guidance for technical conditions under the provisions of Article 49 paragraph (1) and Article 52 paragraph (1) of the Telecommunications Business Law. (3) Ordinance concerning Technical Conditions Compliance Approval and Certification of the Type for Terminal Equipment (Ordinance of the Ministry of Posts and Telecommunications No. 14, 1999) and amendments thereto (Explained in the previous section.) (4) Ordinance for Attested Examiners etc. on Telecommunications Business Law (Ordinance of the Ministry of Posts and Telecommunications No. 15, 1999) and amendments thereto The purpose of this Ministerial Ordinance shall be, to stipulate matters based on the mandate of the Telecommunications Business Law with respect to the attestation of and execution of examination by persons who have obtained attestation under Article 50-2 paragraph (1) of the Law and persons who have obtained attestation under Article 50-3 paragraph (1) of the Law, as well as other matters necessary for enforcing the provisions of the Law. (5) Radio Law (Law No. 131, 1950) and amendments thereto (Explained in the previous section.) (6) Ordinance Regulating Radio Equipment (Radio Regulatory Commission Regulations No. 18, 1950) and amendments thereto The purpose of these Regulations is to determine the conditions for radio equipment and high frequency-based equipment. The regulations are based on the provisions in Chapter III of the Law. (7) Ordinance concerning Technical Regulations Conformity Certification of Specified Radio Equipment (Ordinance of the Ministry of Posts and Telecommunications No. 37, 1981) and amendments thereto 27

38 (Explained in the previous section.) (8) Ordinance concerning Attested Private Inspectors etc. (Ordinance of the Ministry of Posts and Telecommunications No. 76, 1997) and amendments thereto The purpose of these regulations is to provide for the matters designated by the Law and the matters necessary to enforce the provisions of the Law concerning Attested Private Inspectors and Attested Private Foreign Inspectors Designating Authorities Implications for European Designating Authorities The Designating Authorities of the EU Member States, as listed below are responsible for designating the CABs located on their territory. This involves designating, monitoring, withdrawing the designation of, suspending the designation of and withdrawing the suspension of the designation of the CABs that conduct conformity assessment procedures based on the requirements set out in the applicable laws, regulations and administrative provisions of Japan. The Designating Authorities assess and determine that a CAB within its territory fulfils the criteria of the other Party. When applying the criteria for designation of the CABs, Designating Authorities of the EU Member States should take into account the CABs understanding of and experience relevant to the requirements set out in the applicable laws, regulations and administrative provisions of Japan. Up to date information on listed CABs can be found at the DG Enterprise web-site at: < European CABs should contact with European Designating Authorities listed below; LIST OF DESIGNATING AUTHORITIES (EMC AND R&TTE) Name (1) Bundesministerium für Verkehr, Innovation und Technologie, Department IV/4 Country AUSTRIA Address Kelsenstrasse 7 City A-1030 WIEN 28

39 Contact information Last name MARXT First name Walter Title Responsible Officer Phone Number Address Walter.Marxt@bmv.gv.at Name (2) Ministère des Affaires économiques Administration de l Energie Country BELGIUM Address 16, bd du Roi Albert II City B-1000 BRUSSELS Contact information Last name MERKEN First name Vincent Title Mr Phone Number Fax Number Address Vincent.Merken@mineco.fgov.be Name (3) National Telecom Agency (Telestyrelsen) Country DENMARK Address Holsteinsgade 63 City DK-2100 COPENHAGEN Contact information Last name JONSSON First name J Ø rn Title Senior Officer Phone Number Fax Number Address jj@tst.dk Name (4) (Kauppa- ja teollisuusministeriö) Ministry of Trade and Industry Country FINLAND Address P.O. Box 32 City FIN Government, FINLAND Contact information Last name Ahvenainen First name Seppo 29

40 Title Deputy Director General Phone Number Fax Number Address seppo.ahvenainen@ktm.fi Name (5) Ministère de l Economie, des Finances et de l Industrie des Technologies de l Information et des Postes (DiGiTiP) Country FRANCE Address R&TTE EMC 12, rue Villiot 64-70, Allée de Bercy City F PARIS Cedex 12 F PARIS Cedex 12 Contact information Last name MONTACER BERGER First name Ilham Michel Title Chargé de mission/desk officer Ingénieur Phone Number Fax Number Address ilham.montacer@industrie.gouv.fr michel.berger@industrie.gouv.fr Name (6) Federal Ministry of Economics and Labour Department VII B 5 (Bundesministerium für Wirtschaft und Arbeit BMWA Referat VII B 5) Country GERMANY Address Villemomblerstrasse 76 Office/Büro: Haus L, Raum City D BONN Contact information Last name STIBITZ First name Otfried Title Deputy Head of Division/Regierungsdirektor Phone Number Fax Number Address otfried.stibitz@bmwa.bund.de Name (7) Country Ministero delle Comunicazioni Direzione Generale per la Regolamentazione et Qualità dei Servizi/Divisione III ITALY 30

41 Address viale America 201 City I ROMA Contact information Last name BACCINI First name C. Title Mr. Phone Number Fax Number Address Name (8) National Telecommunications and Post Commission (EETT) Country GREECE Address Kifissias 60 City GR Maroussi Contact information Last name IRINI First name Mathiou Title M. Phone Number Fax Number Address Name (9) Department of Public Enterprise, Communications division Country IRELAND Address 44 Kildare Street City DUBLIN 2 Contact information Last name MOORE First name Des Title Responsible Officer for Designation under MRA Phone Number Fax Number Address DesMoore@dpe.ie Name (10) Country Address City Contact information Last name Service de l Energie de l Etat LUXEMBOURG 34 Av. De la Porte-Neuve BP10 LUX-2010 Luxembourg Hoffmann 31

42 First name J-P. Title Mr. Phone Number Fax Number Address Name (11) Ministry of Economic Affairs, Radiocommunications Agency Netherlands, Country NETHERLANDS Address Emmasingel 1 Mailing address: P.O Box 450 City NL-9700 GRONINGEN Contact information Last name COENRAADS First name Jan Title Director Phone Number Fax Number Address jan.coenraads@at-ez.nl Name (12) Anacom Country PORTUGAL Address Alto de Paimão City P Barcarena Contact information Last name Pedrosa de Barros First name Manuel Filipe Title Mr. Phone Number Fax Number Address manuel.barros@anacom.pt Name (13) Secretaria de Estado de Telecomunicaciones y Para la Sociedad de la Información Country SPAIN Address Palacio de Comunicaciones, s/n City E MADRID Contact information (Spanish Permanent Representation to the European Union) Last name Merry del Val First name Fernandez 32

43 Title Phone Number Fax Number Name (14) Swedish Board for Accreditation and Conformity Assessment SWEDAC Country SWEDEN Address P.O Box 2231 City S Stockholm Contact information Last name Ljung First name Malin Title Ms Phone Number Fax Number +46 (0) adress malin.ljung@swedac.se Name (15) Department of Trade and Industry Country UNITED KINGDOM Address 151 Buckingham Palace Road City LONDON SW1W 9SS Contact information Last name MAXWELL First name Diana Title Head of Terminals Unit, CII3d Room 205 Phone Number Fax Number Address Diana.Maxwell@dti.gsi.gov.uk Above data are as of AN Designating Authorities in Japan Designating Authorities in Japan are in charge of Japanese CABs. They are the following authorities or authorities succeeding them: For Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity and amendments thereto: Ministry of Public Management, Home Affairs, Posts and Telecommunications 33

44 For Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility and Council Directive 73/23/EEC of 19 February 1973 on the harmonization of the laws of Member States relating to electrical equipment designed limits and amendments thereto: Ministry of Public Management, Home Affairs, Posts and Telecommunications Ministry of Economy, Trade and Industry 1.4. The Applicable Laws, Regulations and Administrative Provisions Stipulating the Criteria for Designation of Conformity Assessment Bodies The criteria to be applied by the European Community in designating conformity assessment bodies to assess products against Japan s requirements (1) Telecommunications Business Law (Law No. 86, 1984) and amendments thereto (2) Ordinance concerning Technical Conditions Compliance Approval and Certification of the Type for Terminal Equipment (Ordinance of the Ministry of Posts and Telecommunications No. 14, 1999) and amendments thereto (3) Ordinance for Attested Examiners etc. on Telecommunications Law (Ordinance of the Ministry of Posts and Telecommunications No. 15, 1999) and amendments thereto (4) Radio Law (Law No. 131, 1950) and amendments thereto (5) Ordinance concerning Technical Regulations Conformity Certification of Specified Radio Equipment (Ordinance of the Ministry of Posts and Telecommunications No. 37, 1981) and amendments thereto (6) Ordinance concerning Attested Private Inspectors etc. (Ordinance of the Ministry of Posts and Telecommunications No. 76, 1997) and amendments thereto 1.5 Japan s Conformity Assessment Infrastructure for Telecommunications Terminal Equipment and Radio Equipment 34

45 [Chart 7] 35

46 1.6. Technical Regulation Conformity Certification System Stipulated in the Radio Law What is the Technical Regulations Conformity Certification System? This certification system was established to achieve simplification and rationalization of administrative work for license application and to alleviate the burden borne by license applicants. In this system, the Minister of Public Management, Home Affairs, Posts and Telecommunications or a person designated by the Minister of Public Management, Home Affairs, Posts and Telecommunications (designated certification bodies) certifies specific radio equipment such as cellular telephones used in small-scale radio stations specified by applicable ordinances of the Ministry of Public Management, Home Affairs, Posts and Telecommunications as conforming to technical regulations prescribed in the Radio Law (Article 38-2 (1)) prior to the installation. Certified specified radio equipment will be granted either a simplified license application procedure, which does not require an inspection after the completion of construction work, a blanket license that covers specified radio stations, or a determination that a license is not required, depending on the type of the equipment. 36

47 [Chart 8] Technical Regulations Conformity Certification System Minister of Public Management, Home Affairs, Posts and Telecommunications Designate Broadcasting stations, fixed stations etc. Normal licensing procedures (Radio Law Article 6-12) Pre-permit (Article 8) Inspection after completion of construction work (Article 10) Licensing (Article 12) Designated Certification Agencies Application by manufacturers, etc. of specified radio equipment to the designated certification agency (Radio Law Article 38-2) TELEC JARD DSP Research, Inc. Chemitox, Inc.. Type 1, 2&3 Amateur rado equipment only Type 1 only Type 1 only Cellular Phone base stations, etc. Simplified Licensing procedures (Radio Law Article 15) Requirement for pre-permit omitted Cellular phones, etc. Blanket License (Radio Law Article 27-2) PHS, cordless telephones, etc. No license required (Radio Law Article 4) Licensing (Radio Law Article 12) Establishment of Radio Stations (permission to Use) Source: Ministry of Public Management, Home Affairs, Posts and Telecommunications 37

48 [Chart 9] Designated Certification Agencies Technical regulations conformity certifications are conducted by the Minister of Public Management, Home Affairs, Posts and Telecommunications, or designated bodies (designated certification agencies.) Currently, four (4) juridical persons, the Telecom Engineering Center (TELEC), the Japan Amateur Radio Development Association, Inc. (JARD), DSP Research, Inc. and Chemitox, Inc. are the designated certification agencies. Their scope of authority are listed below. Designated Certification Specified Radio Equipment Contact TELEC TYPE 1, 2, & 3 All of the Address: Specified Radio Equipment5-7-2, Yashio, Shinagawa-ku, Tokyo TELEC Comprehensive Consultation Section: Tel: JARD Amateur Radio Equipment Address: Kojima Bldg, , Sugamo, Toshima-ku, Tokyo Management Section Tel: DSP Research TYPE 1 Specified Radio Address: Equipment Chemitox TYPE 1 Specified Radio Address: Equipment Esaka-Soliton Bldg II, 4F, , Esaka-cho, Suita-shi, Osaka Certification Section: , Kamiikedai, Ohta-ku, Tokyo Communication Equipment Evaluation Dept. Tel: / 38

49 According to the provisions of Article 33 of the Law for Implementation of the Mutual Recognition between Japan and the European Community and the Republic of Singapore in Relation to Conformity Assessment of Specified Equipment (so called MRA Law of Japan), the specified radio equipment which has been certified as complying with the technical regulations of the Radio Law by a registered foreign conformity assessment body and to which the mark stipulated in the MPHPT ordinance has been affixed, shall be regarded as the specified radio equipment for which conformity with technical regulations of the Radio Law is recognized. TELEFICATION B.V. (Netherlands), has been registered as a registered foreign conformity assessment body and has started conducting Technical Regulations Conformity Certification. Registered Foreign CAB Telefication B.V. Specified Radio Equipment Address: Edisonstraat 12a, NL-6902 PK Zevenaar, The Netherlands Tel: Fax: / Attested Private Inspectors, etc.: Simplification of Procedures In the Technical Regulations Conformity Certification System, a part of the procedures may be omitted when inspection results of a specified radio equipment conducted by an attested private inspector or an attested private foreign inspector that has been recognized by the Minister of Public Management, Home Affairs, Posts and Telecommunications have been submitted. Recognized domestic and foreign attested private inspectors are categorized into four; Type I Examination Service, Type II Examination Service, Type III Examination Service and The Examination Service of Specified Radio Equipment. The attested private inspectors categorized as in the Examination Service of Specified Radio Equipment are in charge of examinations for conformity assessment under the Technical Regulations Conformity Certification System. As of August 11, 2003 there are 57 domestic attested private inspectors and 5 foreign attested private inspectors. 39

50 Categories Type I Examination Service Type II Examination Service Radio Equipment, etc. of all radio stations Radio equipment at all radio stations Radio equipment, etc. of the radio stations listed below: 1 Fixed stations 2 Broadcasting stations (only those which have no studio, those which perform community broadcasting and broadcasting for a temporary purpose, and those which perform multiplex broadcasting superimposed on the radio waves of community broadcasting and broadcasting for a temporary purpose.) 3 Coast stations (only those using radio waves of a frequency higher than MHz, but except those established with the aim of performing a telecommunications service and those established to perform services related to public activities.) 4 Aeronautical stations (excluding those established with the aim of dealing with communications related to air traffic control, or performing telecommunications services, etc.) 5 Land stations (excluding coast stations, aeronautical stations, base stations, portable base stations, paging stations, and land mobile relay stations.) 6 Ship stations 7 Aircraft radio stations (excluding those established in the aircraft to be used for regular air transport business provided in Article 2, paragraph 17 of the Civil Aeronautical Law (Law No. 231, 1952) before amendment under the provisions of the Law for Amending Part of the Civil Aeronautical Law (Law No. 72, 1999.) 8 Mobile stations (excluding ship stations, automatic distress messaging stations, onboard communications stations, aircraft stations, land mobile stations, and portable stations.) 9 Radiotermination stations (excluding radionavigation land stations, radionavigation mobile stations, radiolocation land stations, radiolocation mobile stations, and radiobeacon stations.) 10 Radiolocation land stations 11 Earth station (excluding coastal earth stations, aeronautical earth stations, portable base earth stations, ship earth stations, aircraft earth stations, and portable earth stations.) a. Those which communicate with broadcasting satellite stations, broadcasting test satellite stations, or development test stations performing broadcasting established on artificial satellites (only those which move.) b. Those applicable to the radio equipment conditions prescribed in Article 40-quarter, paragraph 6 and Article 54-3 of the Equipment Regulations. 12 Portable base earth stations 13 Ship earth stations 14 Aircraft earth stations 15 Emergency radio stations 16 Experimental radio stations (only those to be otherwise announced.) 17 Amateur radio stations 18 Radio stations that fall under the Type III Examination Service category. 40

51 Type III Examination Service *The Examination Service of Specified Radio Equipment Radio equipment, etc. of the radio stations listed below: 1 Fixed stations (only those with a single channel) 2 Base stations 3 Portable base stations 4 Paging stations 5 Land stations 6 Ship stations (only those of fishing vessels (other than those engaged solely in catching marine products and excluding fishing vessels of 300 gross tons or more used for international navigation) and those other than compulsory ship stations established on vessels other than fishing vessels) 7 Automatic distress messaging stations 8 Onboard communications stations 9 Land mobile relay stations 10 Portable stations 11 Radionavigation mobile stations 12 Radio location land stations (only those which use emissions of a frequency of 426.0MHz, GHz, GHz, 24.2GHz, or 35.98GHz) 13 Radiolocation mobile stations 14 Ship earth stations (only those of fishing vessels (other than those engaged solely in catching marine products and excluding fishing vessels of 300 gross tons or more used for international navigation) and those of vessels other than fishing vessels (excluding vessels prescribed in Article 4 of the Ships Safety Law (Law No. 11, 1933) (including the case in which the provisions of Article 29-7 of the Ships Safety Law))) 15 Portable mobile earth stations 16 Experimental radio stations (only those to be otherwise announced.) 17 Convenience radio stations 18 Premises radio stations 19 Meteorological aid stations 20 Stations for special service (excluding those established to perform meteorological reportservices for aircrafts or maritime and aeronautical warnings, etc.) Specified Radio Equipment * The attested private inspectors categorized as in the Examination Service of Specified Radio Equipment are in charge of examinations under the Technical Regulations Conformity Certification System. 41

52 List of Attested Private Inspectors in charge of examinations for the Technical Regulations Conformity Certification System as of May 22, 2003 Name Tel URL Attested Private Inspectors 1 PANASONIC MOBILE COMMUNICATIONS CO / 2 KENWOOD CO. / 3 NIPPON ERICSSON K. K / 4 KDD IMSAT, Inc / 5 NEC MOBILING, LTD / mobiling.com 6 SONNY SOUND COMMUNICATION TOSHIBA DIGITAL MEDIA ENGINEERING CO / dme.co.jp 8 CHEMITOX, Inc / emc.co.jp 9 MOTOROLA JAPAN LTD / 10 FUJITSU LTD / 11 PIONEER COMMUNICATIONS CO / pcc.co.jp 12 DOCOMO ENGINEERING INC / e.co.jp 13 MATSUSHITA ELECTRIC INDUSTRIAL CO / 14 PANASONIC MOBILE COMMUNICATIONS CO / 15 OKI ELECTRIC INDUSTRY CO / 16 VERTEX STANDARD CO / 17 MOTOROLA JAPAN LTD / 18 TAMURA ELECTRIC WORKS, LTD / 19 NIPPON COMSYS CO / 20 JAPAN RADIO CO / 21 TANIZAWA SEISAKUSHO LTD / 22 KODEN ELECTRONICS CO / electronics.co.jp 23 TOM TSUSHIN IND N/ A 24 SHINWA UNITEC CO / unitec.co.jp 25 SANKYO-TOKUSHU COMMUNICATION K.K / tm.co.jp 26 THE NIPPON SIGNAL CO / 27 HITACHI LTD / 28 MOTOROLA JAPAN LTD / 29 TAIYO MUSEN CO / 30 SANGIKYO CO / 31 NOKIA JAPAN CO. / 32 CUBIC-I N/A 33 MATSUSHITA ELECTRIC INDUSTRIAL CO / 34 HITACHI MOBILE CO / 35 TÜV OHTAMA CO / ohtama.co.jp 36 HITACHI ADVANCED SYSTEMS CO / as.co.jp 37 ORIX RENTEC CO / 38 JSAT CO / 39 TÜV RHEINLAND JAPAN LTD / 40 CIRCUIT DESIGN, INC / 41 NISSEI ELECTRONICS IND.CO / denshi.co.jp 42 YAMAZAKI KOGYO / 43 MATSUSHITA ELECTRIC INDUSTRIAL CO / 44 TATEYAMA KAGAKU IND. CO / 45 FURUNO LABOTECH INTERNATIONAL CO / labotech.co.jp 46 KOBE TSUSHIN N/A 47 COMMUTURE CORP / 48 DSP RESEARCH, INC / 49 KINRYO ELECTRIC CO / electric.co.jp 50 ALINCO, INC / 42

53 51 SANYO MULTIMEDIA TOTTORI CO mmt.com 52 SONY TAIYO CO SONY EMCS CO KYOCERA CO DATATrak Co., Ltd / 56 EMC Japan / japan.emc.com 57 UL APEX / Attested Foreign Private Inspectors 1 ERICSSON RADIO SYSTEMS AB Sweden 2 NOKIA NETWORKS OY Sweden 3 A.D.C. AUTOMOTIVE DISTANCE CONTROL SYSTEMS GMBH, Germahttp:// gmbh.de 4 INTEL CORPORATION EARL France 5 TÜV RHEINLAND TAIWAN LTD Taiwan Specified Radio Equipment The specified radio equipment is categorized into three types and each designated certification agency is specified for each category. (1) Type 1: Specified Radio Equipment (License not required) - PHS terminals, digital cordless, telephone terminals, etc. (2) Type 2: Specified Radio Equipment (Blanket license stations) - Cellular telephone terminal, etc. (3) Type 3: Specified Radio Equipment (Others) - Amateur radio equipment, etc. 43

54 Items of Specified Radio Equipment Ordinance of MPT No. 37, 1981 (Ordinance concerning Technical Regulations Conformity Certification of Specified Radio Equipment) TYPE 1 Citizen radio Article 2 item (3) Cordless telephone Article 2 item (7) Specified low power radio equipment Article 2 item (8) Low power security system Article 2 item (13) Low power data communications system in the 2.4GHz band Article 2 item (19) Low power data communications system in the 2.4GHz band Article 2 item (19)-2 Low power data communications system in the 5.2GHz band Article 2 item (19)-3 Low power data communications system in the 25GHz and 27GHz bands Article 2 item (19)-4 Land mobile station for 5GHz band wireless access system (low power type) Article 2 item (19)-13 Digital cordless telephone Article 2 item (21) PHS land mobile station Article 2 item (22) Mobile station for dedicated short range communications system Article 2 item (32) Test station for dedicated short range communications system Article 2 item (33)-2 TYPE 2 Aeronautical portable radio telephone Article 2 item (1)-2 MCA Article 2 item (1)-4 Airport MCA Article 2 item (1)-8 VSAT Article 2 item (9) TDMA cellular phone Article 2 item (10) CDMA cellular phone Article 2 item (11) DS-CDMA cellular phone Article 2 item (11)-3 MC-CDMA cellular phone Article 2 item (11)-4 MC-CDMA 1xEV-DO high-speed wireless communications system Article 2 item (11)-7 Land portable mobile earth station Article 2 item (14) Portable mobile earth station for Orbcomm system Article 2 item (14)-2 Land mobile station for 26/38GHz band subscriber radio access communication Article 2 item (15)-2 (point-to-multipoint type) Land mobile station for 5GHz band wireless access system Article 2 item (19)-7 Land mobile station for 5GHz band wireless access system (low spurious type) Article 2 item (19)-8 Land mobile station for 5GHz band wireless access system (limited for use in Article 2 item (19)-11 Special Zones) Land mobile station for 5GHz band wireless access system (low spurious type) Article 2 item (19)-12 (limited for use in Special Zones) Digital MCA (1.5GHz band) Article 2 item (20) Digital MCA (800MHz band) Article 2 item (20)-2 S-band portable mobile earth station Article 2 item (28) Portable mobile earth station for Iridium system Article 2 item (28)-2 INMARSAT portable mobile earth station Article 2 item (30) Rural subscriber radio Article 2 item (31) Land mobile station in the 60GHz band (point-to-multipoint type) Article 2 item (31)-3 44

55 TYPE 3 SSB for land mobile station and portable radio station Article 2 item (1)-9 Angle-modulation system for land mobile station and portable radio station (F3E Article 2 item (1)-10 etc.) Frequency modulation system for land mobile station and portable radio station Article 2 item (1)-11 (F3E etc.) Specified radio microphone Article 2 item (1)-12 DSB maritime mobile telephone Article 2 item (1)-13 SSB maritime mobile telephone less than 50W Article 2 item (1)-14 Frequency modulation system Article 2 item (1)-15 Radiolocation Article 2 item (2) Radio buoys Article 2 item (2)-2 Meteorological aids Article 2 item (3)-2 Convenience radio (900MHz band) Article 2 item (4) Convenience radio (150,400MHz band) Article 2 item (4)-2 Convenience radio (350MHz band) Article 2 item (4)-3 Convenience radio (27MHz band) Article 2 item (4)-4 Convenience radio (50GHz band) Article 2 item (5) Premises radio Article 2 item (6) Base station for TDMA cellular phone Article 2 item (10)-3 Base station for CDMA cellular phone Article 2 item (11)-2 Base station for DS-CDMA cellular phone Article 2 item (11)-5 Base station for MC-CDMA cellular phone Article 2 item (11)-6 Base station for MC-CDMA 1xEV-DO high-speed wireless communications system Article 2 item (11)-8 Amateur station Article 2 item (12) Base station for 26/38GHz band subscriber radio access communication (point-tomultipoint Article 2 item (15) type) Base station for 22/26/38GHz band subscriber radio access communication (pointto-multipoint Article 2 item (15-3) type) Fixed station for telemeter and broadcasting type simplex communication Article 2 item (16) Fixed station for emergency alarms in the 60MHz band Article 2 item (17) Fixed station for telecommunications service in the 22GHz band Article 2 item (18) Base station for 5GHz band wireless access system Article 2 item (19)-5 Base station for 5GHz band wireless access system (low spurious type) Article 2 item (19)-6 Base station for 5GHz band wireless access system (limited for use in Special Article 2 item (19)-9 Zones) Base station for 5GHz band wireless access system (low spurious type) (limited Article 2 item (19)-10 for use in Special Zones) PHS base station Article 2 item (23) PHS relay station Article 2 item (23)-2 PHS test station Article 2 item (23)-3 Fixed station for telecommunications service in the 38GHz band Article 2 item (24) RZSSB system Article 2 item (25) Automatic frequency selecting RZSSB system Article 2 item (25)-2 Frequency tracking RZSSB system Article 2 item (25)-3 Narrow-band digital system Article 2 item (25)-4 Automatic frequency selecting Narrow-band digital system Article 2 item (25)-5 Frequency tracking Narrow-band digital system Article 2 item (25)-6 Vehicle detection system Article 2 item (26) Beacon system Article 2 item (27) Radar Class III Article 2 item (28)-3 Radar Class IV Article 2 item (29) Base station in the 60GHz band Article 2 item (31)-2 Land mobile station in the 60GHz band (point-to-point type) Article 2 item (31)-4 Base station for dedicated short range communications system Article 2 item (33) Fixed station for subscriber wireless access system in the 1.9GHz band Article 2 item (34) Fixed station for subscriber wireless access system in the 1.9GHz band Article 2 item (35) Relay fixed station for subscriber wireless access system in the 1.9GHz band Article 2 item (36) Test fixed station for subscriber wireless access system in the 1.9GHz band Article 2 item (37) Fixed station for the municipal digital disaster prevention service in the 60MHz band Article 2 item (38) (The above list is as of April 1, 2003) 45

56 Three Ways to Proceed the Technical Regulations Conformity Certification System (1) Technical regulations conformity certification (Radio Law Article 38-2) For each radio equipment, the testing and certification are conducted. The example of this certification procedure by TELEC is shown below. [Chart 10] Flow of Technical Regulations Conformity Certification (Example of TELEC) Applicant Test Pre-Meeting Confirmation of Connectability to Measuring System and Check of Documents Test Report Application To TELEC Select one of two application methods Test by Attested Private Inspector Test by TELEC Examination Test Examination of Document Test (Sampling) R Identification Code Marking By TELEC for Each Unit Issue of Certification For Each Unit Report Ministry of Public Management, Home Affairs, Post and Telecommunications (2) Type Certification (Radio Law Article 38-16) Testing is conducted on one sample unit for each type of radio equipment for certification by type. An example of this type testing by TELEC is shown below. 46

57 [Chart 11] Flow of Type Certification (Example of TELEC) Applicant Test Pre-Meeting Confirmation of Connectability to Measuring System and Check of Documents Test Report Application To TELEC Select one of two application methods Test by Attested Private Inspector Test by TELEC Examination Test Examination of Document Test (For ONE Sample) R Identification Code Marking By Applicant or TELEC Issue of Certification For Each Type Report Ministry of Public Management, Home Affairs, Post and Telecommunications (3) Recognized Certification Body System (Radio Law Article 38-17) This is a system for the Minister of Public Management, Home Affairs, Posts and Telecommunications to recognize a certification body that conducts inspection of radio equipment under foreign statute, when it makes an application certifying that a specified radio equipment that is to be used in Japan complies with technical standards of the Radio Law. No certification body has been recognized yet Technical Conditions Compliance Approval System Stipulated in the Telecommunications Business Law What is the Technical Conditions Compliance Approval System? According to the Telecommunications Business Law, the telecommunications business is classified 47

58 into Type I Telecommunications Business and Type II Telecommunications Business; Type II Telecommunications Business is divided into Special Type II and General Type II Telecommunications Business. A commercial enterprise that has its own network facilities and provides a telecommunications service is, therefore categorized into Type I telecommunications carrier. When a user with terminal equipment wishes to connect that terminal to the Type I telecommunications carrier s network, the terminal equipment must conform to technical conditions that are based on the Telecommunications Business Law. The user can connect its terminal equipment to the network by having the carrier inspect it for conformity to the conditions. However, to eliminate the troublesomeness of this, and to facilitate the use of the various kinds of terminals that are widely distributed in the market, a system for certifying the conformity of telecommunications terminals to the technical conditions has been established. (Article 50: (Technical Conditions Compliance Approval of Terminal Equipment) and Article 50-4: (Certification of Type of Terminal Equipment) of the Telecommunications Business Law.) In this system, the terminal is inspected prior to being used, and at the request of the manufacturers, conformity to the technical conditions are certified by Designated Approval Agencies in Japan or Recognized Approved Bodies overseas based on the amended law in 1998 (Article 68). [Chart 12] Technical Conditions Compliance Approval System Minister of Public Management, Home Affairs, Posts and Telecommunications Designate Designated Approval Agencies Application by manufacturers, etc. of terminal equipment to the designated approval agency (Telecommunications Business Law) JATE, TUV Rheinland Japan Ltd., DSP Research, Inc. and Chemitox, Inc. Connecting to the Type I Telecommunications Carrier s Network (Inspection of Connection of Terminal Equipment by the Type I telecommunications carriers) 48

59 Designated Approval Agencies The Minister of Public Management, Home Affairs, Posts and Telecommunications commission a designated person, called Designated Approval Agency to conduct the technical conditions compliance approval according to the classification stipulated in the applicable ministerial ordinance of the Ministry. There are four (4) agencies approved so far. (1) JATE: Japan Approvals Institute for Telecommunications Equipment Address: Isomura Building, 1-1-3, Toranomon, Minato-ku, Tokyo , Japan Tel: , (Equipment Approvals Department) Fax: (2) TÜV Rheinland Japan Ltd. Address: , Shin-Yokohama, Kohoku-ku, Yokohama , Japan Tel: Fax: (3) DSP Research, Inc. Address: , Esaka-cho, Suita-shi, Osaka Tel: (4) Chemitox, Inc. Address: , Kamiikedai, Ootaku, Tokyo Tel: According to the provisions of Article 31 of the Law for Implementation of the Mutual Recognition between Japan and the European Community and the Republic of Singapore in Relation to Conformity Assessment of Specified Equipment (so called MRA Law of Japan), the terminal equipment which has been certified as complying with the technical conditions of the Telecommunications Business Law by a registered foreign conformity assessment body and to which the mark stipulated in the MPHPT ordinance has been affixed, shall be regarded as the terminal equipment for which conformity with technical conditions of the Telecommunications Business Law. TELEFICATION B.V. (Netherlands), has been registered as a registered foreign conformity assessment body and has started conducting Technical Conditions Compliance Approval. 49

60 Registered Foreign CAB Telefication B.V. Terminal Equipment Address: Edisonstraat 12a, NL-6902 PK Zevenaar, The Netherlands Tel: Fax: / Recognized Approval Body Within the system the Minister of Public Management, Home Affairs, Posts and Telecommunications recognizes the person who engages in investigation or examination of terminal equipment under the regulation for investigation of terminal equipment based on foreign laws or rules and regulation similar to technical conditions compliance approval and who intends to approve the terminal equipment which will be used in Japan. No approval body has been recognized yet Attested Examiners, etc. Within the system the results of the examination of terminal equipment conducted by the person, who undertake to examine terminal equipment and have received the attestation from the Minister of Public Management, Home Affairs, Posts and Telecommunications may be used to obtain technical conditions compliance approval through Designated Approval Agency or Recognized Approval Body. Attested Examiners Type of Business Contact Point [Attested Examiner] DSP Research, Inc. Type 1 Chemitox, Inc. Type 1 emc.co.jp Adsystems Corporation Type 2 RICOH Co., Ltd. Type 2 OKI Engineering Co., Ltd. Type 2 Pioneer Communications Corporation Type 2 pcc.jp TÜV Rheinland Japan Ltd. Type 1 KENWOOD Corporation Type 1 NTT Advanced Technology Corporation Type 1 at.co.jp AKZO NOBEL K. K. Type 2 ORIX Rentec Corporation Type 1 Miyakawa Electric Works Ltd. Type 2 COSMOS Corporation Type 2 Matsushita Electric Works, Ltd. Type 1 UL Apex Type 2 / [Attested Foreign Examiner] Electronics Testing Center, Taiwan BABT/TÜV America Type 2 Integran, Inc. Type 2 co.jp TÜV Rheinland Taiwan Ltd. Type 2 Underwriters Laboratories Inc. Type 2 *Above data is as of August,

61 [Chart 13] Flowchart of Technical Conditions Compliance Approval System Stipulated in the Telecommunications Business Law Attestation Minister of Public Management, Home Affairs, Posts and Telecommunications Designation Recognition Overseas Designated Approval Agencies (JATE, TUV Rheinland Japan and DSP Research) Approval Recognized Approval Body (none) Approval Application Application Attested Examiners Attested Foreign Examiners Japanese Manufacturers Foreign Manufacturers Test Reports 51

62 [Chart 14] Flow of Technical Conditions Compliance Approval (Example of JATE) Applicant Test Pre-Meeting Confirmation of Connectability to Measuring System and Check of Documents Test Report Application To JATE Select one of two application methods Test by Attested Examiner Test by JATE Examination Test Examination of Document Test (Sampling) T Identification Code Marking By JATE for Each Unit Issue of Certification For Each Unit Report Ministry of Public Management, Home Affairs, Post and Telecommunications 52

63 F l o w o f T y p e A p p r o v a l ( E x a m p l e o f J A T E ) A p p l i c a n t T e s t P r e - M e e t i n g T e s t R e p o r t A p p l i c a t i o n E x a m i n a t i o n S e l e c t o n e o f t w o a p p l i c a t i o n m e t h o d s T e s t b y A t t e s t e d E x a m i n a r T e s t b y J A T E T e s t T I d e n t i f i c a t i o n C o d e M a r k i n g I s s u e o f C e r t i f i c a t i o n R e p o r t M i n i s t r y o f P u b l i c M a n a g e m e n t, H o m e A f f a i r s, P o s t a n d T e l e c o m m u n i c a t i o n s tc o o M n f e i r a m s a u t r i i o n n g o S f y C s t o e n m n e a c n t d a b i l i t y C h e c k o f D o c u m e n t s T o J A T E E x a m i n a t i o n o f D o c u m e n t T e s t ( F o r O N E S a m p l e ) B y A p p l i c a n t o r T E L E C F o r E a c h T y p e [Chart 15] 1.8. Amendment of MRA related Laws Contents of Amendment of MRA related Laws regarding Conformity Assessment System The amendment of Radio Law regarding Conformity Assessment System on Specified Radio Equipment and Telecommunications Business Law on Terminal Equipment were promulgated respectively on June 06, 2003 and July 24, Principal points of amendment are as follows. The effective date of the amendment will be announced within nine (9) months after the promulgation. It seems that related rules and regulations to define the concrete contents are under preparation. * The CAB designation system by The Ministry of Public Management, Home Affairs, Posts and Telecommunications (hereinafter called MPHPT) will be changed to registration system. * The attestation system under MPHPT, such as Attested Private Inspectors, Attested Foreign Private Inspectors, Attested Examiners and Attested Foreign Examiners, will be abolished due to the fact that certification CABs will be able to use the test data of third party organizations by their own judgement. * The Self Verification System (so called SDoC) will be introduced for almost all Terminal Equipment and for part of Specified Radio Equipment. (This amendment is not directly related to MRA.) Effects on MRA Following points are possible effects on MRA: * The title of Designated Certification Agencies and Designated Approval Agencies will be changed to Registered Certification Agencies and Registered Approval Agencies. (The practical activities as certification CABs are unchanged.) * Up to now, Designated Certification Agencies (after the amendment, it will be changed to Registered Certification Agencies) and Designated Approval Agencies (after the amendment, it will be changed to Registered Approval Agencies) have been limited to utilize the test data provided by only Attested Private Inspectors, Attested Foreign Private Inspectors, Attested Examiners and Attested Foreign Examiners. After the amendment, Registered Certification Agencies and Registered Approval Agencies will be able to utlize the test data provided by third party agencies by their own judgement (MPHPT will not 53

64 intervene in the judgement of the third party agencies' technical competence). Please refer Chart 16 regarding flow chart of conformity assessment, testing and marking to distribute in Japan after the amendment. 54

65 [Chart 16] Registered EC-CABs as Certification Bodies Conformity Assessment Examination of Document Marking Test or Utilization of Test Data Issue of Certification Distribution Test Data Registered EC-CABs as Tessting Bodies Manufacturers, Testing Laboratories, etc. Market in Japan Registered EC-CABs as Certification Bodies may utilize, at their discretion, test data generated by any outside organizations such as Manufacturers or Testing Laboratories Observation: By the amendment of MRA related Laws, following changes seems to be executed; 1. Organizations which will provide test data could be manufacturers or testing laboratories etc. chosen by Registered EC-CABs as Certification Bodies by their own discretion. 2. However, Registered EC -CABs as Certification Bodies have to be registered based on EU-Japan MRA by EC designating authorities as heretofore. Source: MTA Japan Co., Ltd. 55

66 Annex II: Electrical Products 2.1. Overview Electrical Appliance and Material Safety Law and Other Related Regulations for the MRA The followings are the laws and regulations related to Electrical Products in MRA, Electrical Appliance and Material Safety Law (Law No.234, 1961, hereinafter the Law ). Cabinet Order of the Electrical Appliance and Material Safety Law (Cabinet Order No.324, 1962, hereinafter, the Cabinet Order ). Ordinance of the Electrical Appliance and Material Safety Law (Ordinance of the Ministry of International Trade and Industry No.84, 1962, hereinafter, the Ordinance ). Ordinance concerning Technical Requirements for Electrical Appliances and Materials (Ordinance of the Ministry of International Trade and Industry No.85, 1962, hereinafter the Technical Requirements Ordinance ). Working Regulations for the Ordinance concerning Technical Requirements for Electrical Appliances and Materials ( No.6. (2002)), hereinafter, the Working Regulations ). Assessment Criteria etc. relating to Actions of Ministry of Economy, Trade and Industry based on Electrical Appliances and Material Safety Law etc (13 Gen No.8 (2001), hereinafter, the Assessment Criteria ). Article 35 of the Law for Implementation of the Mutual Recognition between Japan and the European Community in relation to Conformity Assessment of specified equipment (Law No.111,2001, hereinafter, the MRA Implementation Law ). Ordinance concerning International Certificates based on Article 35 of the Law for Implementation of the Mutual Recognition between Japan and the European Community in relation to Conformity Assessment of specified equipment (Ordinance of the Ministry of Economy, Trade and Industry, No.208 of 2001, hereinafter 35 Ordinance ) Classification of Electrical Appliances and Materials (Article No.2 of the Law) In Article 2 of the Law, electrical appliances and materials covered by the Law are designated and they are divided into two categories; a) Specified Electrical Appliances and Materials and b) Other Electrical Appliances and Materials a) List of Specified Electrical Appliances and Materials (112 items as of end of April 2003) 56

67 As stated in the , fundamental laws and regulations to sell electric appliances in Japan is Electrical Appliance and Material Safety Law and other related regulations. Products considered with particularly high risks to cause hazards or interference, which require concrete procedure of pre-marketing and marking requirement as stated in NO Electrical Appliances and Materials NO Electrical Appliances and Materials Rubber-Insulated Cables 43 Earth leakage circuit breakers 1 Rubber insulated cables 44 Attachment plugs 2 Rigid Cables(Rubber) 45 Socket-outlets 3 Single-core rubber cords 46 Multitaps 4 Twisted rubber cords 47 Cord connector bodies 5 Textile braided rubber cords 48 Flatiron plugs 6 Round braided rubber cords 49 Appliance connectors 7 Other rubber cords 50 Other plug couplers 8 Sheathed flexible cords(rubber) 51 Cord reels 9 Sheathed flexible cables(rubber) 52 Screw-in rosettes 10 PVC sheathed flexible cables(rubber) 53 Hook-up rosettes Plastic-Insulated Cables 54 Other rosettes 11 Synthetic resin insulated cable 55 Keyless sockets 12 Rigid Cables (Synthetic resin) 56 Waterproof sockets 13 Single-core PVC cords 57 Key sockets 14 Twisted PVC insulated cords 58 Pull sockets 15 Textile braided PVC cords 59 Pushbutton sockets 16 Round braided PVC cords 60 Other sockets 17 Other PVC cords 61 Split sockets 18 Single-core polyethylene cords 62 Separable plug bodies 19 Other polyethylene cords 63 Other screw couplers 20 Sheathed flexible cords (PVC) 64 Adaptors 21 Tinsel cords 65 Lamp receptacles 22 PVC sheathed flexible cables 66 Fluorescent lampholders Link Fuses 67 Fluorescent starter holders 23 Link fuses 68 Joint boxes Enclosed Fuses Current Limiters 24 Tubular fuses 69 Meter rate current limiters 25 Other enclosed fuses 70 Flat rate current limiters Thermal Links Single-Phase Small Power Transformers 26 Thermal links 71 Transformers for toys Wiring Devices 72 Other household appliance transformers 27 Tumbler switches 73 Ozonizer stabilizing transformers 28 Rotary switches 74 Electronic appliance transformers 29 Pushbutton switches 75 Fluorescent lamp ballasts 30 Pull switches 31 Cord switches 76 Mercury vapor lamp ballasts and other high pressure discharge ballasts 32 Pendant switches Heating Appliances 33 Other switches 77 Electric heated toilet seats 34 Time switches 78 Heating appliances for garden plants 35 Streetlamp switches 79 Electric hot cupboards 36 Photoelectric automatic switches 80 Electric inhalators 57

68 37 Cutout 81 Electric steam baths 38 Box switches 82 Electric heaters for steam baths 39 Molded case circuit breakers 83 Electric sauna baths 40 Float switches 84 Electric heaters for sauna baths 41 Pressure switches 85 Electric storage water heaters 42 Sewing machine controllers 86 Electric pipe freeze prevention heaters NO Electrical Appliances and Materials NO Electrical Appliances and Materials Heating Appliances 101 Electric bubble generators for bathtubs 87 Glass dew-prevention heaters 102 Electric bubble generators for aquariums 88 Other electric heating appliances for 103 Other electric bubble generators prevention of freezing or condensation 104 Electric motor-operated toys 89 Aquarium heaters 105 Electric amusement vehicles 90 Household heating therapeutic appliances 91 Electric heated toys 106 Other electric motor-operated or electromagnetically driven amusement appliances Electric Motor-Operated Appliances Electronic Appliances 92 Automatically washing and drying toilets 107 High-frequency depilators 93 Electric food waste disposers Other AC Appliances 94 Electric pumps 108 Magnetic therapeutic appliances 95 Electric well pumps 109 Electric insect killers 96 Refrigerating showcases 110 Electric therapeutic bath controllers 97 Freezing showcases 111 Power supplies 98 Electric ice cream freezers Potable Engine Generators 99 Electric massagers 100 Vending machines 112 Portable engine generators 58

69 b) List of Other Electrical Appliances and Materials (340 items) Products considered to cause hazards or interference. NO Electrical Appliances and Materials NO Electrical Appliances and Materials Rubber-Insulated Cables Wiring Devices 1 Cable(Rubber) 41 Remote control relays 2 Arc welding electrode cables(rubber) 42 Cutout switches 3 Heating cables(rubber) 43 Covered knife switches Plastic-Insulated Cables 44 Panelboard unit switches 4 Fluorescent lamp cables 45 Electromagnetic switches 5 Neon tube cables 46 Lighting tracks 6 Cable(Synthetic resin) 47 Lighting track couplings 7 Arc welding electrode cables(synthetic 48 Lighting track elbows resin) 8 Heating cables(synthetic resin) 49 Lighting track tees Metal Conduits 50 Lighting track crosses 9 Metal conduits 51 Lighting track feed-in boxes 10 Metal under floor ducts 52 Lighting track end caps 11 Class I metal raceways 53 Lighting track plugs 12 Class II metal raceways 54 Lighting track adaptors 13 Class I flexible metal conduits 55 Other lighting track fittings and connectors 14 Class II flexible metal conduits Single-Phase Small Power Transformers 15 Other flexible metal conduits 56 Transformers for bells Metal Conduits Fittings 57 Transformers for indicators 16 Metal couplings 58 Transformers for remote control relays 17 Metal normal bends 59 Transformers for neon tubes 18 Metal elbows 60 Transformers for fire lighters 19 Metal tees 61 Ballasts for sodium vapor lamps 20 Metal crosses 62 Ballasts for germicidal lamps 21 Metal caps 63 Voltage regulators 22 Metal connectors Small A.C. Motors 23 Metal boxes 64 Repulsion start induction motors 24 Metal bushings 65 Split-phase induction motors 25 Other metal fittings of rigid conduits or 66 Capacity-start induction motors flexible conduits 67 Capacity-run induction motors 26 Cable wiring switch boxes(metal) 68 Commutator motors Plastic Conduits 69 Shaded-pole induction motors 27 Plastic conduits 70 Other single-phase motors 28 Pliable plastic conduits 71 Squirrel-cage three-phase induction motors 29 CD conduits Heating Appliances Plastic Conduits Fittings 72 Electric room heaters 30 Plastic couplings 73 Japanese electric heaters (Hibachi) 31 Plastic normal bends 74 Electric kotatsu 32 Plastic elbows 75 Electric anka 33 Plastic connectors 76 Electric foot warmers 34 Plastic boxes 77 Electric slippers 35 Plastic bushings 78 Electric comforters (Futon) 36 Plastic caps 79 Electric floor cushions 59

70 37 Other plastic fittings of rigid conduits or 80 Electric blanket flexible conduits 81 Electric underblankets 38 Cable wiring switch boxes(plastic) 82 Electric carpets Enclosed Fuses 83 Electric seat chair covers 39 Tubular fuses 84 Electric knee rugs 40 Plug fuses 85 Electric heated chairs NO Electrical Appliances and Materials NO Electrical Appliances and Materials Heating Appliances 131 Electric flatirons 86 Other electric heating appliances for body 132 Electric plastic welders heating purposes 133 Electric immersion heaters 87 Electric buffet ranges 134 Electric instantaneous water heaters 88 Electric ranges 135 Electric heating boards 89 Electric sausage roasters 136 Electric heating floor sheets 90 Electric toasters 137 Electric heating floor mats 91 Electric fish roasters 138 Electric plant nurseries 92 Electric ovens 139 Electric egg incubators 93 Electric roasters 140 Electric brooders 94 Electric waffle irons 141 Electric dryers 95 Electric tacoyaki griddles 142 Electric clothes pressers 96 Electric cooking heating plates 143 Electric moxibustion appliances 97 Electric frying pans 144 Electric insecticide vaporizers 98 Electric deep pans 145 Electric incense burners 99 Electric rice cookers Electric Motor-Operated Appliances 100 Electric fryers 146 Electric room fans 101 Electric kettles 147 Ventilating fans 102 Electric coffee makers 148 Electric circulating fans 103 Electric milk warmers 149 Electric cooled air fans 104 Electric steamers 150 Electric fan-coil units 105 Electric boiled egg makers 151 Electric fan convectors 106 Electric ricewine warmers 152 Electric deodorizers 107 Electric bains marie 153 Electric fragrance diffusers 108 Electric tea servers 154 Blowers 109 Electric warming trays 155 Electric room air-conditioners 110 Electric warming boards 156 Electric dehumidifiers 111 Electric jars 157 Electric hot air heaters 112 Electromagnetic cookers 158 Electric hair dryers 113 Other electric heating appliances for 159 Laminators cooking purposes 160 Electric dryers 114 Electric sterilizers (with electric heaters) 161 Electric air cleaners 115 Thermostatic developing trays 162 Electric vacuum cleaners 116 Electric curling irons 163 Electric blackboard eraser cleaners 117 Electric hair curlers 164 Electric record cleaners 118 Electric hair steamers 165 Other electric dust absorbers 119 Electric hot water heaters for shaving 166 Electric floor polishers 120 Other electric heating appliances for skin 167 Electric shoe polishers and hair care 168 Electric washing machines 121 Electric air humidifiers 169 Electric spin extractors 122 Electric hot handtowel steamers 123 Electric clothes steamers 124 Electric soldering irons 171 Electric dishwashers 125 Electric heated knives 172 Electric vegetable washers 170 Electric washing machines for sports goods or recreational goods 60

71 126 Electric pottery kilns 173 Electric humidifiers 127 Electric heaters for irons 174 Electric fountains 128 Electric melters 175 Air compressors 129 Other electric heating tools for handwork 176 Electric mist sprayers and handicraft 177 Electric refrigerators 130 Electric irons NO Electrical Appliances and Materials NO Electrical Appliances and Materials Electric Motor-Operated Appliances 225 Electric pencil sharpeners 178 Electric freezers 226 Electric stirring machines 179 Electric water coolers 227 Electric inhalators 180 Electric ice makers 228 Finger pressure (shiatsu) simulators 181 Electric juice squeezers 182 Juice blenders 229 Other electric motor-operated or magnetically-driven appliances for household therapeutic use 183 Food processors 230 Electric mimeograph machines 184 Electric coffee mills 231 Vending machines 185 Electric dried bonito planers 232 Handtowel rolling machines 186 Electric rice washers 233 Handtowel wrapping machines 187 Electric rice polishers 234 Electric tea leaf roasters 188 Electric ice flakers 235 Electric insect traps 189 Electric rice cake (mochi) makers 236 Electric game machines 190 Electric noodle makers 237 Electric bells 191 Electric can openers 238 Electric buzzers 192 Electric mincers 239 Electric chimes 193 Electric meat choppers Electric Motor-Operated Appliances 194 Electric bread slicers 240 Electric sirens 195 Electric shavers 241 Belt conveyors 196 Electric hair clippers 242 Electric threshing machines 197 Electric nail polishers 243 Electric rice hulling machines 198 Other electric motor-operated or 244 Electric straw dampers magnetically -driven appliances for skin or 245 Electric straw rope making machines hair care 199 Electric toothbrushes 246 Egg selectors 200 Electric brushes 247 Egg washers 201 Electric scissors 248 Electric seatangle (Konbu) processors 202 Electric grinders 249 Dried cuttlefish processors 203 Electric sanders 250 Wrapping machines 204 Electric polishers 251 Packaging machines 205 Electric drills 252 Electric table clocks 206 Electric planers 253 Electric wall clocks 207 Electric saws 254 Electric music boxes 208 Electric metal cutting machines 255 Automatic print fixing baths 209 Electric hand shears 256 Automatic print washers 210 Electric groovers 257 Office printing machines 211 Electric mortisers 258 Addressing machines 212 Electric tube cleaners 259 Time recorders 213 Electric scaling machines 260 Time stampers 214 Electric tappers 261 Electric typewriters 61

72 215 Electric nut runners 262 Electric account selectors 216 Electric screwdrivers 263 Shredders 217 Electric cutting blade polishers 264 Electric paper cutters 218 Other electric power tools 265 Electric collators 219 Electric lawnmowers 266 Electric staplers 220 Electric grass shears 267 Electric paper punches 221 Electric hedge trimmers 268 Numbering machines 222 Electric garden cultivators 269 Checkwriters 223 Electric pottery wheels 270 Coin counters 224 Electric sewing machines 271 Bill counters 62

73 NO Electrical Appliances and Materials NO Electrical Appliances and Materials Electric Motor-Operated Appliances 305 Television receiver boosters 272 Label tagging machines 306 Ultrasonic humidifiers 273 Laundry finishing machines 307 Ultrasonic cleaners 274 Laundry folding machines 308 Ultrasonic rat exterminators 275 Money changers 309 Microwave ovens 276 Electric barber chairs 310 High-frequency welders 277 Electric fan-forced air heaters 311 Household low frequency therapeutic appliances 278 Electric musical instruments 312 Household ultrasonic therapeutic appliances 279 Electric hot water circulator/purifiers for bathtubs (24-hours operation whirlpool bath) 313 Household ultra-short wave therapeutic appliances Luminaries and Optical Appliances 314 Electronic recreational appliances 280 Pedestal lighting fixtures 315 Electronic clocks 281 Household pendant fluorescent lamp 316 Electronic tabletop calculators lighting fixtures 317 Electronic cash registers 282 Rechargeable flashlights 318 Electronic refrigerators 283 Handlamps 319 Interphones 284 Garden lighting fixtures 320 Electronic musical instruments 285 Decorative lighting fixtures 321 Radio receivers 286 Copying machines 322 Tape recorders 287 Slide projectors 323 Record players 288 Overhead projectors 324 Juke boxes 289 Episcopes 325 Other audio equipment 290 Microfilm readers 326 Video tape recorders 291 Viewers 327 Demagnetizers 292 Electronic flash apparatuses Other AC Appliances 293 Photographic enlargers 328 Leakage current detectors 294 Photographic enlarger lamphouses 329 Burglar alarms 295 Photographic printers 330 Producers of medical materials 296 Electric sterilizers 331 Household electric potential therapeutic appliances 297 Household therapeutic ray appliances 332 Electric refrigerators (absorption system) 298 Incandescent lamps 333 Arc welding machines 299 Fluorescent lamps 334 Electric fence energizers 300 Other incandescent lamp fixtures 335 Electric dimmers 301 Other discharge lamp fixtures 336 Radio interference suppression devices 302 Advertising lights 337 Furnitures with lamps 303 Egg testers 338 Furnitures with electrical outlets Electronic Appliances 339 Furnitures with other electrical appliances 304 Television receivers 340 Electric pencils Outline from Pre-Market Measures, Marking Requirements to Post-Market Measures 63

74 The followings are measures from pre-marketing to post-market measures and these measures are obligated to importers in Japan. (1) Report of Business Commencement (Article No.3 of the Law). For all Electrical and Appliances and Materials. (2) Compliance with Technical Requirements (Article No.8 of the Law) For all Electrical Appliances and Materials Self declaration of conformity Conduct testing and keep records (3) Third party certification requirements (Article No.9 of the Law) Only for Specified Electrical Appliances and Materials (4) Marking Requirements For all Electrical Appliances and Materials (5) Post market measures; Order for improvement (Article 11 of the Law) Restriction on sale (Article 27 of the Law) Restriction on use (Article 28 of the Law) Order for the Prevention of Hazards (Article 12 of the Law) Order for the Submission of Report (Article 45 of the Law) On-site inspection (Article 46 of the Law) Order for submission of the Electrical Appliance and Material (Article 46-2 of the Law) Penalty (Article 57 of the Law) 64

75 Concrete Procedure of Pre-Marketing and Marking Requirement (1) Pre-market measures for manufacturers There are three ways for manufacturers. (a) [Chart 17] In the Case that European Exporters Use Japanese CABs 65

76 (b) [Chart 18] In the Case that European Exporters Use Approved CAB in Europe (c) There is another way to utilize Registered CABs based on MRA Law. However, there is no registered CABs in Japan nor in Europe existed. [Chart 19] In the Case of Other Electrical Appliances and Materials 66

77 (2) Marking Requirement (a) In the case of Specified Electrical Appliances and Materials i) The symbol of Safety Mark for Specified Electrical Appliances and Materials ii) The Reporting Supplier's name or legal name iii) The name or legal name of the CAB by which the certificate was issued iv) Others required from the Technical Requirements (b) In the case of Other Electrical Appliances and Materials i) The symbol of Safety Mark for Other Electrical Appliances and Materials ii) The Reporting Supplier's name or legal name iii) Others required from the Technical Requirements 2.2 Implication for European Designating Authority Through MRA, European exporters will be facilitated the access to Japanese market if number of Registered CABs will be increased either in Japan or in Europe in case electric products fallen into the category of Specified Electrical Appliances and Materials. In addition to such efforts, it is expected to increase the number of Approved CABs in Europe so that European exporters would have easy access to the conformity services to export to Japan. The list of European Designating Authorities for EU CABs to contact is as follows: LIST OF DESIGNATING AUTHORITIES (LVD) 67

78 Country: AUSTRIA Name: Friedrich Birkhan Bundesministerium für Wirtschaft und Arbeit Address: Abteilung I/14 Landstraßer Hauptstraße A-1030 Wien Phone: Fax: Address: friedrich.birkhan@bmwa.gv.at Web Address: Country: BELGIUM Name: Bernard PICRON Ministère des Affaires économiques - Economic Affairs Address: Bld du Roi Albert II, Bruxelles Phone: Fax: Address: Bernard.PICRON@mineco.fgov.be Web-Address: Country: DENMARK Name: Jan Roed Elektricitetsrådet Address: Gothersgade 160 DK-1123 København K. Denmark Phone: Fax: Address: jan.roed@elraadet.dk Web-address: Country: FINLAND Name: Reijo Mattinen Safety Technology Authority, Electrical Safety (TUKES) Address: P.O.Box

79 FIN Hensilki Finland Phone: Fax: Address: reijo.mattinen@tukes.fi Web-address: Country: FRANCE Name: Michel Berger Ministère de l Economie, des Finances et de l Industrie DiGITIP/SPIC/SQUALPI Address: DiGITIP 5 Le Bervil 12 rue Villiot F Paris Cedex 12 France Phone: Fax: Address: michel.berger@industrie.gouv.fr Web-address: Country: GERMANY Name: ZLS - Zentralstelle der Länder für Sicherheitstechnik, c/o Bayerisches Staatsministerium für Gesundheit, Ernährung und Verbraucherschutz, Address: Postfach , D München, Dienstgebäude: Bayerstr. 32, D München, Tel.: od. 211 Fax: Address: zls@stmgev.bayern.de Country: Name: Address: GREECE Ministry of Development General Secretary of Industry 4th Direction of Industrial Policy 69

80 Sisini 8 GR Athens Tel.: ext Fax: Address: mousouros@ypan.gr Country: IRELAND Name: Evelyn Kelly Office of the Director of Consumer Affairs Address: 4 Harcourt Road Dublin 2 Ireland Phone: Fax: Address: evelyn_kelly@entemp.ie Web-address: Country: ITALY Name: Emilio FEDERICI Ministero Industria Address: DGSPC" via molise, Roma Italia Phone: Fax: Address: federici@minindustria.it Web-address: Country: Name: Address: Address: LUXEMBOURG Romain Nies Service de l'energie de l'etat 34 avenue de la Porte-Neuve, BP10, L-2010 Luxembourg Phone: Fax: Romain.nies@eg.etat.lu 70

81 Web-address: Country: NETHERLANDS Name: Pierre Hellwig Ministry of Health, Welfare & Sport; Public Health Dept Address: P. O. Box NL-2500 BC The Hague Netherlands Phone: Fax: Address: Web-address: Country: PORTUGAL Name: Cristina Bragança Instituto Português da Qualidade Address: Rua António Gião,nº Caparica Portugal Tel.: Fax.: Address: Country: SPAIN Name: José Felix Rodriguez Ministerio de Ciencia y Tecnología Address: Dirección General de Politica Tecnologica Paseo de la Castellana, 160 E Madrid Spain Phone: Fax: Address: jrm5@mcyt.es Web-address: Country: SWEDEN 71

82 Name: Ingvar Enqvist Swedish National Electrical Safety Board Address: P.O. Box 1371 S Stockholm Sweden Phone: Fax: Address: ingvar.enqvist@elsakerhetsverket.se Web-address: Country: UNITED KINGDOM Name: Pritum Shah DTI Address: 151 Buckingham Palace Road London SW1W 9SS United Kingdom Phone: Fax: Address: pritum.shah@dti.gsi.gov.uk Web-address: Implication for European Conformity Assessment Bodies Outline of Actual Approved CAB and Authorized CAB in Japan based on the Law The following is the outline of conformity assessment bodies related structure based on the Law Article 9, 29 and

83 [Chart 20] Outline of Conformity Assessment Bodies Related Structure Based on the Electrical Appliance and Material Safety Law The status of Authorized CABs and Approved CABs are equal. METI conducts the internal assessment for the application of Authorized / Approved CABs in accordance with Part I, A-2 of the Assessment Criteria. 6 Authorized CABs and 4 Approved CABs have been designated as of April The following is the list of Authorized CABs and Approved CABs as of April (1) List of Authorized Conformity Assessment Bodies 1 Japan Electrical Safety and Environment Technologies Laboratories, (JET) 2 Japan Quality Assurance Organization, (JQA) 3 Japan Electric Cable Technology Center Inc., (JECTEC) 4 TÜV Rheinland Japan Ltd. 5 Cosmos Co., Ltd. 6 UL APEX Co., Ltd. 73

84 (2) List of Approved Conformity Assessment Bodies 7 Underwriters Laboratories Inc. 8 UL International DEMCO A/S 9 Intertec Testing Services Hong Kong Ltd TÜV Rheinland Product Safety GmbH Conformity Assessment Issue in Electrical Application and Material Safety Law and its Relationship with the MRA (Article 35 of the MRA Implementation Law and the Article 35 of Ordinance) (1) Conformity Assessment Certificate Issue The followings are outline of results of conformity assessment and certificates issued by Registered CABs under MRA. Result of Conformity Assessment conducted by Registered CABs under MRA between EC and Japan shall be treated as having the same legal effect with the result of Conformity Assessment conducted by Authorized / Approved CABs under Electrical Appliance and Material Safety Law. Registered CABs under MRA between EC and Japan will issue a International Certificates as the result of their Conformity Assessment as stipulated in 35 of the MRA Implementation Law. The followings are matters which would be described in international certificates. (a) Name of Registered Conformity Assessment Body (b) Representation that the body has been registered as a conformity assessment body under Article 9, Paragraph 1 of the Agreement on Mutual Recognition between Japan and the European Community (hereinafter referred to as the Agreement ) (c) Name or legal name and address of applicant (d) Type Classification of Specified Electrical Appliance and Material (e) Name and address of plant or place of business manufacturing the Specified Electrical Appliance and Material (for importer, the name and address of the manufacturer 74

85 manufacturing the Specified Electrical Appliance and Material and the name and address of the plant or place of business manufacturing the Electrical Appliance and Material) (f) Method of test (g) Fact of conformity with the Technical Requirements stipulated by Article 8, Paragraph 1 of the Electrical Appliance and Material Safety Law (Law No. 234, 1961) and the standards stipulated by the Ordinance of the Ministry of Economy, Trade and Industry noted by Article 9, Paragraph 2 of the same law (only for tests relating to the Article, Paragraph 1, Item 2 of the same law) (h) Date of issue of certificate Content of International Certificates is the same as content of Certificate under the Electrical Appliance and Material Safety Law except (b) above. Registered CAB shall refer their own status under the MRA in their International Certificates. (2) Control Measures for Authorized/Approved CABs Other than procedure described (1) above, European exporters can use Authorized CABs and Approved CABs. Followings are control measures for Authorized/Approved CABs. (Article 40,40-2,42-3, ,52 of the Law) (a) In the case of Authorized CABs (For Japanese Bodies) Order for Compliance Order for Improvement Order to perform conformity assessment based on the application from Reporting Suppliers Order for submission of reports to METI On-Site Inspection by METI (b) In the case of Approved CABs (For Foreign Bodies) Request for Compliance Request for Improvement Request to perform conformity assessment based on the application from Reporting Suppliers (METI may request) Submission of reports (METI may request) On-Site Inspection (3) Cancellation of Authorization etc 75

86 (Article 41, 42-4 of the Law) (a) In the case of Authorized CABs (For Japanese Bodies) Cancellation of the Authorization Order for Suspension from the Operation of the Conformity Assessment in whole or part in the specified period Purview of Disqualification (Article 30) Violation of Article 33, Article 34, Article 35, Article 36 or 42 Violation of Order for Compliance or Order for Improvement Violation of Conditions attached at the Authorization Authorization through fraudulent means (b) In the case of Approved CABs (For Foreign Bodies) Cancellation of the Approval (METI may request) Suspension of the Operation of the Conformity Assessment in whole or part in the specified period Purview of Disqualification(Article 30) Violation of Article 33, Article 34, Article 35, Article 36 or 42 Violation of Request for Compliance or Request for Improvement Violation of Conditions attached at the Approvals (c) Approval through fraudulent means Failure to the request of suspension of the operation of the conformity assessment, etc. Failure to the request of submission of reports, etc. Refuse of the on-site inspection, etc. Non payment for the expense for spot inspection 2.4. Implication for European Manufacturers (Emphasizing Small and Medium Sized Companies) In case European manufactures export products fall into the category of Specified Electrical Appliances and Materials (112 items), European manufacturers must contact either with an Authorized CAB in Japan or an Approved CAB in Europe as stated in Annex II page 11 (a) and (b). In case European manufacturers export products do not fall into the category of Specified Electrical 76

87 Appliances and Materials (112 items), including but not limited to Other Electrical Appliances and Materials (340 items), European exporters shall have statistical report to contact with Approved CABs or importers in Japan as stated in Annex II page 11 (b) and page 12. In case European manufacturers face problem of inability to find an Approved CAB, they should make a report of this problem with the appropriate European Designating Authority to try to increase the number of Registered CABs under MRA. By above efforts, access to Japanese market will be facilitated through MRA. 77

88 [Chart 21] 78

89 Annex III: Good Laboratory Practice (GLP) for Chemical Products 3.1. Overview: GLP Related Laws and Regulations The applicable laws, regulations and administrative provisions stipulating the principles of GLP (and web site) are as follows. a. Pharmaceutical (i) Pharmaceutical Affairs Law (Law No.145,1960) and amendments thereto. (ii) Other related regulations for Pharmaceutical Ordinance prescribing Standards for the Conduct of Non-clinical Laboratory Studies on Safety of Drugs (Ordinance of the Ministry of Health and Welfare No.21, 1997) and amendments thereto. Treatment of Materials concerning Non-clinical Laboratory Studies on Safety of Drugs which should be attached to the Application for the Product (import) Approval etc. (Yakushin No.253 (1997), Yakuan No.29 (1997) and amendments thereto. Establishment of the Guidelines for the conduct of GLP On-site Inspection (Yakushin No.254 (1997), Yakuan No.30 (1997) and amendments thereto. b. Veterinary Drugs (i) Fundamental law regarding veterinary drugs Pharmaceutical Affairs Law (Law No.145, 1960) and amendments thereto. (ii) Other regulations regarding veterinary drugs Ordinance prescribing Standards for the Conduct of Non-clinical Laboratory Studies on Safety of Veterinary Drugs (Ordinance of the Ministry of Agriculture, Forestry and Fisheries No.74, 1997) and amendments thereto. Management of the Pharmaceutical Affairs Law (12 Chiku A No.729 (2000) and amendments thereto. c. Agricultural Chemicals 79

90 (i) (ii) Agricultural Chemicals Regulation Law (Law No.82, 1948) and amendments thereto. (Only in Japanese) Other regulations related to agricultural chemicals The Proper Implementation of Toxicological Studies on Agricultural Chemicals (11 Nosan No.6283 (1999) and amendments thereto. d. Feed Additives (i) Law concerning Safety Assurance and Quality Improvement of Feed (Law No.35, 1953) and amendments thereto. (ii) Other regulations related to Feed Activities Standards for the Conduct of Animal Studies on Feed Activities (63 Chiku A No.3039 (1988) and amendments thereto. The Establishment of the Guidelines for the Inspection based on the Standards for the Conduct of Animal Studies on Feed Additives (1 Chiku A No.3441 (1990) and amendments thereto. e. New Substances and Designated Substances (i) Law concerning the Examination and Regulation of Manufacture etc. of Chemical Substances (Law No.117, 1973) and amendments thereto. (ii) Other regulations related to New Substances and Designated Substances Standard concerning Testing Facility Provided for in Article 4 of the Ordinance prescribing Test Items etc. Relating to New Chemical Substances and Toxicity Research of Designated Chemical Substances (Kanpogyo No.39 (1984)-Yakuhatsu No.229 (1984) 59 Kikyoku No.85 (1984) and amendments thereto. Test Results Used as Criteria for Determination at the Examination etc. of New Chemical Substances (Eisei No.39)(1988)-63 Kikyoku No.822 (1988) and amendments thereto. f. Substances Controlled for the Prevention of Health Hazard of Workers (i) Industrial Safety and Health Law (Law No.57, 1972) and amendments thereto. (ii) Other regulations related to Substances Controlled for the Prevention of Health 80

91 Hazard of Workers The Standard to be Satisfied by the Test Facility etc. under the Provision of Article 34-3(2) of the Ordinance on Industrial Safety and Health (Notice of the Ministry of Labour No.76, 1988) and amendments thereto. Implementation of the Ordinance to Amend a Part of the Ordinance on Industrial Safety and Health, the Ordinance to Amend a Part of the Ordinance on Safety of Boiler and High Pressure Vessels and the Ordinance to Amend a Part of the Ordinance on Preventing Organic Solvents Poisoning, etc.(kihatsu No.602(1988) and amendments thereto. The Establishment of the Guideline of Certification of Compliance of Test Facilities etc. with GLP under the Industrial Safety and Health Law (Kihatsu No.123 (1989) and amendments thereto Implication for European GLP Monitoring Authorities Contact Points with European GLP Monitoring Authorities Below shows the list of European GLP Monitoring Authorities. EU National Authorities under GLP Austria Bundesministerium für Land- und Forstwirtschaft, Umwelt und Wasserwirtschaft Address: Abteilung I/3 Stubenbastei 5 A-1010 Wien Tel.: (43-1) or 48 Fax: (43-1) or Web: Contacts: Dr Gottfried Gidaly gottfried.gidaly@bmlfuw.gv.at Dr Susanna Schragner susanna.schragner@bmlfuw.gv.at 81

92 Belgium Institut scientifique de la santé publique Louis-Pasteur Wetenschappelijk Instituut Volksgezondheid Bureau d'assurance qualité Rue Juliette Wytsman 14 Juliette Wytsmanstraat 14 B-1050 Bruxelles B-1050 Brussel Tel.: (32-2) or Fax: (32-2) Web: Contacts: M. Hedwig BEERNAERT M. Joris van LOCO Denmark Lægemiddelstyrelsen (Danish Medicines Agency) Frederikssundsvej 378 DK-2700 Brønshøj Tél. : (45) Fax : (45) Web : Contact: Ms Annette Byrholt HANSEN abh@dkma.dk DANAK Erhvervsfremme Styrelsen (Danish Agency for Trade and Industry) Erhvervsministeriet (Ministry of Trade and Industry) Dahlerups Pakhus Langelinie Allè 17 DK-2100 København Ø Tel.: (45) Fax: (45) Web: Contact: Ms Lisbeth LUND llu@efs.dk Finland Sosiaali- ja terveydenhuollon tuotevalvontakeskus (STTV) National Product Control Agency for Welfare and Health Kemikaaliosasto Chemicals Department Säästöpankinranta 2A 82

93 PL 210 FIN Helsinki Tel.: Fax: Web: Contact: Dr. Pirkko Puranen pirkko.puranen@sttv.fi France Secrétariat du groupe interministériel des produits chimiques Le Bervil 12, rue Villiot Digitip 2 F Paris cedex 12 Tel.: (33-1) Fax: (33-1) Contact: M. Gérard MATHIEU gerard.mathieu@industrie.gouv.fr Agence française de sécurité sanitaire des produits de santé (AFSSAPS) , boulevard Anatole-France F Saint-Denis Tel.: (33-1) Fax: (33-1) Web: Contact: M me Dominique ABDON dominique.abdon@afssaps.sante.fr Agence française de sécurité sanitaire des aliments (AFSSA) Agence nationale du médicament vétérinaire (ANMV) AFSSA-Lyon 31, avenue Tony-Garnier BP 7033 F Lyon cedex 07 Tel.: (33-4) Fax: (33-4) Web: Contact: M. Jean-Michel SAPIN jm.sapin@anmv.afssa.fr Greece Eλληνικη ηµοκρατια Υπουργειο Οικονοµικων Ministry of Finance General Chemical State Laboratory Division of Environment Section of Dangerous Substances, Preparations, and Articles 83

94 16, An. Tsocha Street GR Athina Tel.: (30-1) Fax: (30-1) Web: Contacts: Mme Angeliki TSATSOU-DRITSA Mme Ioanna ANGELOPOULOU Germany Bundesministerium für Umwelt, Naturschutz und Reaktorsicherheit IG II 3 Postfach D Bonn Tel.: ( ) Fax: ( ) Web: Contact: Prof. Dr Ulrich SCHLOTTMANN schlottmann.ulrich@bmu.de Bundesinstitut für Risikobewertung GLP Bundesstelle Thielallee D Berlin Tel.: ( ) or 36 or 65 Fax: ( ) Contacts: Dr. Hans-Wilhelm HEMBECK Leiter Dr. Wolf BURCHARD BULLING Stellvertretender Leiter Dr. Marina GOTTSCHALK glp-bundesstelle@bfr.bund.de Ireland The Irish National Accreditation Board Wilton Park House Wilton Place Dublin 2 Ireland Tel.: or Fax: Web: Contacts: Mr. Thomas DEMPSEY tom.dempsey@nab.ie Mrs Marie O MAHONY marie.omahony@nab.ie Italy 84

95 Istituto Superiore di Sanità Viale Regina Elena, 299 I Roma Tel: (39-06) Fax: (39-06) Web: Contact: Prof. Dr. Sergio CAROLI Luxembourg Ministère de l Économie 19-21, boulevard Royal L-2449 Luxembourg Tel.: (352) Fax: (352) Contact: M. Jean-Marie REIFF jean-marie.reiff@eco.etat.lu The Netherlands Lux. : ne figure pas dans le JO L284/3 du

96 Ministerie van Volksgezondheid, Sport Dutch Inspectorate for Health Protection Keuringsdienst van Waren (KvW) GLP Department Postbus BC s Gravenhage Nederland Tel.: (31-70) Fax: (31-70) Web: Contacts: Dr Theo HELDER Theo.Helder@KvW.nl Dr Rob M.A. JASPERS Rob.Jaspers@KvW.nl Portugal Instituto português da qualidade (IPQ) Ministerio da Indústria e Comercio Rua C à avenida dos Três Vales P-2825 Monte da Caparica Tel.: (351-21) Fax: (351-21) Web: Contact: Mme Noelia DUARTE nduarte@mail.ipq.pt Instituto nacional de farmácia e do medicamento (Infarmed) Parque de Saúde de Lisboa Avenida do Brasil 53 P-1700 Lisboa Tel.: (351-21) Fax: (351-21) Web: Contact: Mme Celeste FREIRE celeste.freire@infarmed.pt Spain Agencia española del medicamento Subdirección general de Seguridad de medicamentos 86

97 c/ Huertas, 75 E Madrid Web: Contact: Doña Manuela ABUÍN LOPEZ Jefe servicio Inspección Tel.: (34-91) Fax: (34-91) Ministerio de Pesca y Alimentación Secretaria General de Agricultura y Alimentación Dirección General de Agricultura Subdirección General de Medios de Producción Agricolas Avenida Ciudad de Barcelona, 118 E Madrid Web: Contact: Doña Gerna PEREZ AVILES Jefe de sección de inspección Tel.: (34-91) Fax: (34-91) gperezav@mapya.es Ministerio de Ciencia y Tecnologia Subdirector general de Seguridad industrial Paseo de la Castellana 160 PLA 12 E Madrid Contact: Sr Angel TORRES RODRIGUEZ Tel.: (34-91) Fax: (34-91) atr1@mcyt.es Sweden Läkemedelsverket (Medical Products Agency) Box 26 Husargatan 8 S Uppsala Tel.: (46-18) Fax: (46-18) Web: Contact: Mr Ragnar HEDE ragnar.hede@mpa.se Styrelsen för ackredetering och teknisk kontroll (Swedish board for acreditation and conformity assessment) (SWEDAC) Box 2231 S Stockholm 87

98 Tel.: (46-8) Fax: (46-8) Web: Contact: Ms Elsbeth JOHANSSON United Kingdom United Kingdom GLP Compliance Monitoring Authority Department of Health Room 621A, Market Towers 1 Nine Elms Lane Vauxhall London SW8 5NQ United Kingdom Tel.: (44-207) Fax: (44-207) Web: Contact: Dr. Roger ALEXANDER Roger.Alexander@mca.gov.uk Contact Points with Japanese GLP Monitoring Authorities and Related Organizations The following is information regarding various fields of GLP and responsible organizations in Japan. European Designating Authorities shall work with the following organizations to check confirmed facilities of GLP. 88

99 Field Organization Web.Site General Information General Information on the Agreement Ministry of Foreign Affaris of Mutual Recognition First International Economic Affairs Division, Economic Affairs Division Pharmaceutical General Information on pharmaceutical Ministry of Health, Labour and Welfare Licensing and Evaluation Division Pharmaceutical and Food Safety Bureau Veterinary Chemicals General Information on veterinary Ministry of Agriculture, Forestry and chemicals Fisheries Veterinary Drug Administration Office, Animal Health Division, Livestock Industry Department, Agriculture Production Bureau Information on details regarding Ministry of Agriculture, Forestry and GLP of veterinary chemicals Fisheries (Japanese only) (inspection, certificate etc.) Planning and Coordination Division National Veterinary Assay Laboratory Agricultural Chemicals General information on GLP on Ministry of Agriculture, Forestry and Agricultural Chemicals Fisheries Agricultural Chemicals Administration Office Agricultural Materials Division Agriculture Production Bureau General information on GLP on Agricultural Chemicals Inspection Agricultural Chemicals Station Planning and Strategy Office Feed Additives General information on Feed Ministry of Agriculture, Forestry and Additives and Fisheries Feed Division, Livestock Industry Department, Agriculture Production Bureau Information on GLP inspection of Fertilizer and Feed Inspection Station Feed Additives Feed Inspection First Division (Japanese only) Feed Inspection Second Division 89

100 New Substances and Designated Substances Toxicological tests Ministry of Health, Labour and Welfare Office of Chemical Safety Pharmaceutical and Food Safety Bureau Information regarding following 3 test Ministry of Economy, Trade and categories; Industry 1. Physical-chemical testing Chemical Management Policy Division, (Partition coefficient(n-octano/water) Manufacturing Industries Bureau with Shake Flask Method Only) 2. Studies on behavior in water, soil and air; bioaccumulation(bioconcentration using fish Only) 3. Biodegradation using activated sludge Ecotoxicity testng (voluntary) and other Ministry of the Environment environmental issues Chemicals Evaluation Office Environmental Health Department Substances Control for the Prevention of Health Hazard of Workers Inspection issues Ministry of Health, Labour and Welfare Chemical Substances Investigation Regulatory issues Division, Industrial Safety and Health Department Labour Standards Bureau Technical issues National Institute of Industrial Health Library and Information Center 3.3. Japanese GLP Inspection Authorities GLP in Japan are managed by different ministries based on the field stated in 3.1. Conformity Assessment Bodies may contact the following designating authorities and/or organizations to confirm the applicable GLP standards. a. Pharmaceutical Ministry of Health, Labour and Welfare b. Veterinary Chemicals Ministry of Agriculture, Forestry and Fisheries c. Agricultural Chemicals Agricultural Chemicals Inspection Station d. Feed Additives Fertilizer and Fees Inspection Station 90

101 (Only in Japanese) e. New Substances and Designated Substances (i) For toxicological tests: Ministry of Health, Labour and Welfare (ii) Following 3 test categories information: physical-chemical testing/ studies on behavior in water, soil and air/ biodegradation using activated sludge Ministry of Economy, Trade and Industry (METI) The following is the list of laboratories confirmed by METI for GLP based on Law concerning the Examination and Regulation of Manufacturers etc. of Chemical Substances. Base Information: 91

102 GLP Laboratory Chemicals Evaluation and Research Institute, Japan Gakushuin University Ecotoxicology Institute Koei Techno Service Co.,Ltd. Osaka Branch Konica Co., Ltd. Safety Testing Center Sumitomo Chemical Co., Ltd. Daicel Chemical Industries, Ltd. Takasago International Co., Ltd. Takeda Chemical Industries, Ltd. Japan Clinical Laboratories, Inc. Nishiwaki Laboratory Fuji Film Co., Ltd. Hodogaya Contract Laboratory (in Hodogaya Chemcial Co.,Ltd.) Mitsui Chemical Co., Ltd. Safety Testing Center Web Site Japanese Only Japanese Only Only in Japanese Only in Japanese Mitsubishi Chemical Safety Institute, Ltd. Testing Center, Kita-Kyushu Laboratory Mitsubishi Chemical Safety Institute, Ltd. Testing Center,Yokohama Laboratory Mitsubishi Gas Chemical Company, Inc. Niigata Laboratory Lion Corporation, Safety Evaluation Center 3.4. Implication for European Manufacturers (Emphasizing Small and Medium Sized Companies) The following presents the information necessary to meet applicable GLP in Japan and the relevant time in the approval process the information is required. 92

103 Example of necessary information and timing to prepare for GLP Conformity Assessment Related Law Information (1) (2) (3) (4) (5) (6) (7) Facility to be inspected B B A B B B B Name (Japanese& Engligsh) B B A B B B B Address (Japanese& English) B B A B B B B Date of inspection B B B B Objectives of inspection B B B Fields of items of inspection B B B B Outline of testing activities related to GLP application A B A A A B Manual of internal assessment and past 3 years' results B A A Outline of facilities Date of establishment A A A A Founders A A A Corporate Resolution or legal statue of establishment A A A Visual Design of facilities and building B B A B B A B Area of land and facilities B B A B A A A Area and number of floors of building B B A B B A A M ajor facilities,equipment and machines' location B B A B A A B Histrory related to GLP (Starting date of GLP test, past inspection etc) B B B B B Organizatins and Staffs of testing facilities Organization Chart of Company B B A B B B B Organization Chart of GLP testing facility B B A B B B B Structure of staffs related to inspection Total staffs of GLP organization(including contract base staffs) B B B B A B Breakdown of staffs based on level of graduated school,degree etc B B B B Staffs structure based on departments of GLP organization B B A B B A B Activities of management staffs B B B B Criteria to select responsible person for testing activities B B B B Outline of recent training activities for staffs B B A B A A A Experience of testing activities of responsible person for testing B B B B Job description of management staffs(name,title,experience etc) B B A B B A A Orgarnizational structure of quality assurance unit B B B B B Major activities of person belonging to GLP organization B B B B B Capacity to accept animals in testing dedicated department B B B B B Design of facility and air-conditiong in safety (toxity) testing department B B B B B B Numbers, name and serial number of testing equipment B B A B A A B Outline of facilities regarding animal feeding Condition of feeding B B B B B B Data about feed, water, floor materials (name of suppliers etc) B B B B B Monitoring of virus of feeding room B B B B B Environmental control and monitoring procedure of important areas B B B B B Condition of usage of detergent and disinfection Frequency of usage of detergent and disinfection B B B B Usage of insect powder B B B B Major planning B B B Standard Operational Procedure(SOP) SOP and related format of documents B B B Procedure to make, amend and abolish SOP B B B B List of indexes of SOP B B A B B B Flow chart of safety and toxity testing B B B B Outline of computer system B B B B B Outline of sub-contracts B B A B B B Outline of testing which are executed in different places B B B Pointed out issues of GLP inspection and measures of improvement B B B B B 93

104 A: attachment to the application B: before the inspection Blank means not necessary to prepare (1) The Organization for Pharmaceutical Safety and Research Law (2) Ordinance prescribing Standards for the Conduct of non-clinical Laboratory Studies on Safety of Veterinary Drugs (3) Agricultural Chemicals Regulation Law (4) Law concerning Safety Assurance and Quality Improvement of Feed (5) Law concerning the Examination and Regulation of Manufacturers etc.of Chemical Substances (toxity test) (6) Law concerning the Examination and Regulation of Manufacturers etc, of Chemical Substances (analytical test) (7) Industrial Safety and Helath Law Source: Original data from Pharmaceutical Administration in Japan 10 th Edition, Yakuji Nippo, Ltd. 94

105 Annex IV: Good Manufacturing Practice (GMP) for Medical Products 4.1. Overview Historical Background of GMP in Japan Since 1976, Standards for Manufacturing Control and Quality Control of Drugs have been promoted by the Ministry of Health, Labor and Welfare (hereinafter MHLW). After the amendments of the Pharmaceutical Affairs Law in October 1979, the Standards, which were treated as administrative guidance, turned into Regulations to be legally observed by manufacturers and were enforced from September The Law was further amended in April 1993 and the legal status of the regulations was changed from requirements to be observed by drug manufacturers to those as a prerequisite for manufacturing licenses. The regulations were enforced in April 1994, including new validation requirements which became effective in April GMP for investigational products was promulgated in April 1997 by the Pharmaceutical Administration Bureaus (hereinafter PAB) Director-General notification. In addition to the existing GMP, special requirements were made on biological products for manufacturing control and quality control, and for buildings and facilities of the manufacturing plants. They became a prerequisite for manufacturing licenses from October 1997 and April 1999, respectively. With Measures for Relaxation to the Regulations for Selling Drugs published in March 1999, an amendment was made and the Regulations became Regulations for Manufacturing Control and Quality Control of Drugs and Quasi-Drugs Outline of GMP in Japan There are two aspects for GMP in Japan; 1) requirements for manufacturing control and quality control of drugs and 2) requirements for buildings and facilities in drug manufacturing plants. However, GMP requirements for manufacturing control and quality control do not apply to drug manufacturing plants of the followings: (1) Drugs used only for eradication or prevention of rodents, flies, mosquitoes, fleas, etc. and not 95

106 directly applied to human body. (2) Drugs used only as fungicides and disinfectants, and not directly applied to the human body. (3) Drugs used only for in vitro diagnosis. (4) Drugs manufactured at the plants exclusively used for powdering or cutting of crude herbal drugs. (5) Drugs manufactured by a pharmacy owner using facilities and equipment in his pharmacy. (6) Among articles included in the Japanese Pharmacopoeia, those designated by the Minister of Health, Labour and Welfare (Absorbent gauze, absorbent cotton, etc.) (7) Gases for medical use designated by the Minister of Health, Labour and Welfare. GMP provisions in Japan are composed of 1) Regulations for Manufacturing Control and Quality Control of Drugs and Quasi-drugs and 2) Provisions on Buildings and Facilities in Manufacturing Facilities Regulations for Manufacturing Control and Quality Control of Drugs and Quasi-drugs As a component of GMP in Japan, Regulations for Manufacturing Control and Quality Control of Drugs and Quasi-drugs is divided into two factors; 1) Standards Codes and 2) Control System. (1) Standards Codes A drug manufacturer must prepare four standard codes (product master formula, manufacturing control standard code, manufacturing hygiene control standard code, quality control standard code), and manufacturer drugs in accordance with these codes. Product master formula This formula, prepared for each product, describes all information concerning manufacturing control and quality control. Manufacturing control standard code This code provides general rules of manufacturing processes ranging from acceptance of raw materials, labeling and packaging materials, storage of intermediate products and finished products, to the control of manufacturing stages. Manufacturing hygiene control standard code This code is concerned with the health management of manufacturing place and personnel, and prescribed detailed rules for the health management of working rooms, facilities and equipment, health checkup of personnel, and of garments of personnel. 96

107 Quality control standard code This code, intended for proper quality assurance of drugs, gives necessary information on sampling method and evaluation of test results. (2) Control System The control system of GMP in Japan is as follows: [Chart 22] The manufacturing facility must have both a manufacturing control unit and quality control unit. Furthermore these must be independent from each other. These units must be operated respectively by a manufacturing control manager and a quality control manager. A product control pharmacist is designated to make decisions on the release of finished products and to supervise the manufacturing control manager and the quality control manager Provisions on Buildings and Facilities in Manufacturing Facilities 97

108 The second important component of GMP in Japan is Provisions on Buildings and Facilities in Manufacturing Facilities. The standards for buildings and facilities are described in Article 5, 5-2, and 5-3 of the Regulations for Buildings and Facilities for Pharmacies etc, which were enacted based on Pharmaceutical Affairs Law. The Regulations also provide necessary standards of manufacturing facilities for sterile preparations in Article 6, for biological products in Article 7, for blood products not forming a lot in Article 8 etc Standards for the Quality Control of Imported Drugs and Medical Devices (so called GMPI ) The Standards for Quality Control of Imported Drugs and Medical Devices provide requirements to be observed by importers which was published in April 1993 by the Pharmaceutical Administration Bureau (PAB) Director-General Notification. Based on these requirements, the MHLW Ordinance on the Regulations for Imported Drugs and Quasi-drugs Management and Quality Control as well as that on the Regulations for Imported Medical Devices Management and Quality Control were published in June Both of these have been effective as a prerequisite for importing license since August of the same year. The main points of the Regulations are; Matters to be agreed between the importer and the manufacturer in the exporting country other than the basic legal requirements as stated above. Based on the agreements, confirmation by the importer that the drugs and medical devices to be imported are manufactured under appropriate manufacturing and quality control considering such factor as receipt, distribution and storage as well as performance of analysis and testing in accordance with the standard code etc Implication for European Designating Authorities Organizational Structure in Japan Within the Ministry of Health, Labour and Welfare (MHLW), GMP is administered by Pharmaceutical and Medical Safety Bureau (PMSB). PMSB is composed of following five divisions; General Affairs Division, Evaluation and Licensing Division, Safety Division, Compliance and Narcotics Division and Blood and Blood Products Division. Among these five divisions, the Compliance and Narcotics Division has following 98

109 functions; Control of quality defects, falsely labeled products etc. Guidance and supervision related to advertising. Testing and batch release control GMP compliance Matters related to pharmaceutical inspectors Under the MHLW, the following organizations are also in charge of GMP; Regional Bureaus of Health and Welfare (seven: Hokkiasdo/ Tohoku/ Kanto/ Tokai/ Kinki/ Chu-Shikoku/ Kyushu) Forty seven (47) prefecture governments Pharmaceutical Affairs Law and related Laws The legal base of pharmaceutical administration in Japan is composed of following laws; The Pharmaceutical Affairs Law Pharmacists Law Organization for Pharmaceutical Safety and Research Law Poisonous and Deleterious Substances Control Law Bleeding and Blood Donor Supply Service Control Law Narcotics and Psychotropics Control Law Cannabis Control Law Opium Law Stimulants Control Law etc. Among these laws, the Pharmaceutical Affairs Law is the supreme law. Under this Pharmaceutical Affairs Law, the flow chart below illustrates the significant elements from approval review system until evaluation control system. 99

110 [Chart 23] 100