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WORKSHOP “The Regulatory System for Importing Electrical /electronical Goods to Japan ” on

WORKSHOP “The Regulatory System for Importing Electrical /electronical Goods to Japan ” on 2010-06-29 in Tel Aviv by Kurt K. Heinz NCB TÜV Rheinland Japan. Contents :. 1. Electrical Appliance and Material Safety Law (DENAN Law) 2. New Pharmaceutical Affairs Law (PAL)

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WORKSHOP “The Regulatory System for Importing Electrical /electronical Goods to Japan ” on

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  1. WORKSHOP “The Regulatory System for Importing Electrical /electronical Goods to Japan” on 2010-06-29 in Tel Aviv by Kurt K. Heinz NCB TÜV Rheinland Japan

  2. Contents: 1. Electrical Appliance and Material Safety Law(DENAN Law) 2. New Pharmaceutical Affairs Law (PAL) 3. Test and Certification for Telecommunication Products 4. Supplemental explanation on Japanese regulations

  3. 1. Electrical Appliance and Material Safety Law (DENAN Law)

  4. 1. Electrical Appliance and Material Safety Law (DENAN) Explanation for “Denki Yōhin” - Electrical Applianceand Materials In the DENAN, ”Denki Yōhin” is classified into two categories -- “Category A” and “Category B” Category A product ：Need to obtain “Certificate of Conformity (CoC) by Registered Conformity Assessment Body (RCAB)= Registered by Japanese Government. Category B product ：Not necessary to get CoC, but there is the obligation to conform to the Technical Requirements stipulated by the Ministerial Ordinance. Self- verification (confirmation) can be done by manufacturer. NOTE: There are many other products not being in scope of DENAN Law. And, even if subjecting to DENAN, there are also products being in scope of another regulation, e.g., therapeutic apparatus for households use, microwave oven, etc.

  5. 1. Electrical Appliance and Material Safety Law (DENAN) DENAN - Concept of Denki Yōhin* * “Denki Yōhin” = The products specified by “DENAN” Category B products (other electrical appliance and materials) Total : 339 items “Denki Yōhin” = Electrical Appliance and Materials Category A Products (specified electrical appliance and materials) Total : 115 items Category A and Category B Total : 454 items

  6. 1. Electrical Appliance and Material Safety Law (DENAN) Electrical products in Japanesemarket Products controlled by DENAN Products not controlled by DENAN Other electrical products which are not in scope of DENAN (but, may be in scope of other regulations, e.g., Radio Law, Pharmaceutical Affairs Law, etc.) Category B products 339 items Category A products 115items

  7. 1. Electrical Appliance and Material Safety Law (DENAN) In the DENAN Scope? Mobile Phone Out of Scope of DENAN Why? Because it is powered by a battery.

  8. 1. Electrical Appliance and Material Safety Law (DENAN) In the DENAN Scope? Power Supply Device with DC Output Category A AC Electrical Appliance DC Power Supply Unit

  9. 1. Electrical Appliance and Material Safety Law (DENAN) In the DENAN Scope? Power Supply Device without Enclosure Out of Scope of DENAN

  10. 1. Electrical Appliance and Material Safety Law (DENAN) In the DENAN Scope? Extension Cord Set Category A Wiring Devices Multi Tap, Cord, Attachment Plug (respective part)

  11. 1. Electrical Appliance and Material Safety Law (DENAN) In the DENAN Scope? Coffee Maker Category B Electrical Heating Appliance Electric Coffee Maker

  12. 1. Electrical Appliance and Material Safety Law (DENAN) In the DENAN Scope? Hair Dryer Category B Electrical Motor Operated Appliance Electric Hair Dryer

  13. 1. Electrical Appliance and Material Safety Law (DENAN) In the DENAN Scope? DVD Player Category B Electronic Appliance Other Audio Equipment

  14. 1. Electrical Appliance and Material Safety Law (DENAN) In the DENAN Scope? Refrigerator Category B Electrical Motor Operated Appliance Electric Refrigerator

  15. 1. Electrical Appliance and Material Safety Law (DENAN) In the DENAN Scope? Massage Chair Category A Electrical Motor Operated Appliance Electric Massager

  16. 1. Electrical Appliance and Material Safety Law (DENAN) In the DENAN Scope? Paper Shredder Category A Electrical Motor Operated Appliance Shredder

  17. 1. Electrical Appliance and Material Safety Law (DENAN) Conformity Assessment For Category A product For example: DC Power Supply Unit Select Technical Requirement : Clause 1 or Clause 2 Survey for test equipment of manufacturer Product Evaluation（Safety & RFI) Need both compliances OK OK Issue of CoC

  18. 1. Electrical Appliance and Material Safety Law (DENAN) Category A product + Category B product Product Evaluation Safety related RFIrelated (if required) Technical requirement Ordinance Clause 1 Technical requirement Ordinance Clause 1 Selection Technical requirement Ordinance Clause 2 Technical requirement Ordinance Clause 2 NOTE: Clause 1: Japanese original, requirements existing by each designated product Clause 2: based on international standards RFI test is part of Technical Requirements, but not for all.

  19. 1. Electrical Appliance and Material Safety Law (DENAN) Applicable Technical Requirements / Standards Products specified by “DENAN Law” should be tested in accordance with the technical requirements /standards specified by MITI Ordinance Clause 1 or 2 Selection Possible （Chose one） MITI Ordinance for Technical requirements MITI Ordinance for Technical requirements MITI Ordinance Clause 1 MITI Ordinance Clause 2 Technical requirements J-IEC standards （Remarks） Not only Safety requirements but also RFI requirements are included. Technical requirements Appendix 1-8 （Remarks） Not only Safety requirements but also RFI requirements are included. Technical Requirements consist of two standard groups : Category A products / Category B products are required to be tested according to the following standards. (Either Clause 1 or Clause 2) Need to be in compliance with either Clause 1 or Clause 2.

  20. DENAN Flowchart Important！ Is your product in question in the DENAN Law scope??? Out of Scope of DENAN Law No The Law does not apply YES Is your product Category A？or Category B？ Category A product Category B product Japanese Mfr. Flow-Chart (A) Japanese Mfr. Flow-Chart (C) Overseas Mfr. Flow-Chart (D) Flow-Chart (B) Overseas Mfr. 1. Electrical Appliance and Material Safety Law (DENAN)

  21. Overseas Mfr. / Japanese importer for Category A products DENAN Flowchart (B) Request for CoC Conformity assessment (Mandatory) by RCAB Overseas nations Mfr.　who produces Category A product Application Japanese importer ■Product Test according to Technical Requirement Clause 1 or Clause 2 (Safety / RFI ) ■Factory Inspection Site/facility check Business relation Pass “Issue of CoC” Obligation of Japanese Importer（As Notifying Supplier） Overseas Mfr. ■Obligation to keep “CoC” (copy) ■Obligation to check conformity with technical requirements ■Obligation to make and keep inspection records ■ Obligation for marking; “Notifying Supplier’s name” + ”RCAB’s name” + Need to fulfill the obligation as Notifying Supplier “Submittal of CoC -Authorized Valid Copy Business relation Japanese Importer 1. Electrical Appliance and Material Safety Law (DENAN)

  22. Overseas Mfr. / Japanese importer for Category B products DENAN Flowchart (D) Obligation to conform to Technical requirements Overseas Mfr. can apply to 3rd partytesting body for compliance testing (not mandatory = voluntary) 3rd party testing Overseas Mfr.　 who produces “Category B” product Confirmation Japanese importer ■Product Test according to Technical Requirement Clause 1 or Clause 2 (Safety / RFI ) selection Business relation Compliance check by Mfr. by themselves ■Product Test according to Technical Requirement Clause 1 or Clause 2 (Safety / RFI ) Obligation of Japanese Importer（As Notifying Supplier） Self confirmation Overseas manufacturers ■Obligation to check conformity with technical requirements ■Obligation to make and keep inspection records ■ Obligation for marking; “Notifying Supplier’s name” + Need to fulfill the obligation as Notifying Supplier Submittal of the evidence of compliance Business relation Japanese Importer 1. Electrical Appliance and Material Safety Law (DENAN)

  23. Audit / Registration Report upon request Notification of starting business Manufacturer Category A Products Request for CoC (Application) Registered Conformity Assessment Body Registration by METI Legal action if necessary Issue of CoC Ministry of Economy, Trade and Industry (METI) Notifying Supplier Notification of starting business Importer Category A Products Request for CoC (Application) Issue of CoC Legal action if necessary Request for CoC equivalent Submit of CoC equivalent Request for CoC equivalent (Application) Overseas manufacturer (category A product) =(outside Japan) Issue of CoC equivalent 1. Electrical Appliance and Material Safety Law (DENAN)

  24. 1. Electrical Appliance and Material Safety Law (DENAN) Legal marks stipulated by DENAN Law in Japan There are two kinds of legal marks; one for specified electrical appliances and materials and another for other electrical appliances and materials. Marking for Category A(specified electrical appliances and materials ) For electric cables/cords, fuses, wiring devices etc, if there is not enough space for marking, manufacturers, etc. it may be marked as “<PS>E” instead of this Mark. Notifying Supplier’s name and RCAB name who conducted the “Conformity Assessment” have to be indicated near the PSE-diamond mark. Marking for Category B（other electrical appliances and materials ）(those not specified in Category A) For electric cables/cords, conduits and its accessories, fuses, wiring devices etc, if there is no enough space for the notifying supplier’s name, it may be marked as “(PS)E” instead of this Mark. Notifying Supplier’s name has to be indicated near the PSE-Circle mark.

  25. 1. Electrical Appliance and Material Safety Law (DENAN) About METI HP: Information of DENAN is available in http://www.meti.go.jp/english/policy/economy/consumer/pse/index.htmlThe following is an example of information available on the above HP.

  26. 薬 事 法 Yaku Medicine Ji issue, topic Hō law Pharmaceutical Affairs Law 2. New Pharmaceutical Affairs Law (PAL)

  27. http://www.mhlw.go.jp/ 2. Pharmaceutical Affairs Law (PAL) The New PAL – Introduction and Overview Pharmaceutical Affairs Law (PAL, ‘Yakujihō’) Revised by the MHLW effective since 2005-04-01 Article 1: This law is intended to provide regulations required to ensure the quality, efficacy and safety of drugs, quasi-drugs, cosmetics andmedical devicesand to improve the public health and hygiene through necessary measures taken to promote the research and development of drugs and medical devices which are of particular importance to the medical practice.

  28. 2. Pharmaceutical Affairs Law (PAL) The New PAL – Introduction and Overview NEW: Review of the Safety Measures for Medical Devices • New System of Medical Devices Classification • Product Certification of the Designated Controlled Medical Devices (Class II)by Registered Certification Bodies(RCBs)

  29. 2. Pharmaceutical Affairs Law (PAL) New System of Medical Devices Classification [General Medical Devices] – Class I, extremely low riskPotential risk is almost insignificant in case of malfunction or side effect. Examples: scalpel, X-Ray film [(Designated) Controlled Medical Devices] – Class II, low riskHaving potential risk in case of malfunction or side effect. Examples: MRI, electronic sphygmomanometers, gastric catheters [Specially Controlled Medical Devices]– Class III / IV, middle/high riskPotential risk is significant in case of malfunction or side effect. Examples: dialyzer, pacemaker, stent

  30. Classification by PAL Class I Class II Class III Class IV General MD (Designated) Controlled MD Specially Controlled MD Product CertificationProduct Approval no requirements by RCB by MHLW (Application to PMDA) • RCB: Registered Certification Body (Designated) Controlled MD: Designated with certain criteria by MHLW • PMDA: Pharmaceuticals and Medical Devices Agency (Independent Agency of the MHLW) 2. Pharmaceutical Affairs Law (PAL) Product Approval/Certification

  31. 2. Pharmaceutical Affairs Law (PAL) Necessary Approvals / Registrations • Marketing Authorization Holder (MAH) • Resposible for distribution, quality of the product and manufacturing • Responsible for vigilance system • Manufacturer (Manufacturing site) • Manufactures the products upon the order from MAH, products can be sold only to MAH or Manufacturer

  32. Marketing Authorization Holder Supervising function License to Marketing Authorization MAH, (Marketing Approval Holder) GQP supervision GVP supervision QA function Post-marketing safety measures function GQP: Good Quality Practice products Info GVP: Good Vigilance Practice Sales office Domestic factory Overseas factory OEMfactory (retail business) (manufacturing Site ) distributor QC compliant with the revised QMS(GMP) (ISO 13485） hospial

  33. 2. Pharmaceutical Affairs Law (PAL) Marketing Authorization System • ‘License to Marketing Business’  MAH Marketing Authorization Holder • ‘License (Registration) for Manufacture‘ Production License (-Registration) • ‘Device Approval (MHLW) / Certification (RCB)‘Product Approval / Certification

  34. 2. Pharmaceutical Affairs Law (PAL) Special Rules for Foreign Manufacturers • A foreign manufacturer who intends to getproduct approval or product certificate: • Appointment of the Appointed/DesignatedMAH (D-MAH) in Japan (needs the corresponding license). Appointed/Designated MAH(D-MAH) may be: (1) Distributor (2) Third party (3) Company’s subsidiary in Japan

  35. Classification by PAL Class I Class II Class III Class IV General MD Designated Controlled MD Specially Controlled MD Type of Marketing Authorization Holders No. 1 Type License for Marketing Business of Medical Devices No. 3 Type No. 2 Type 2. Pharmaceutical Affairs Law (PAL) License to Marketing Authorization Holder (MAH) • Classification of the MAH Licenses (License for Marketing AuthorizationHolders) Article 12

  36. 2. Pharmaceutical Affairs Law (PAL) License to Marketing Authorization Holder (MAH) • MAH has to be in Japan • Classification of the licenses (for MDs, type 1, 2 & 3) • MAH license renewal: every 5 years(PAL, Article 12, 2.) • Requirements for MAH (e.g. GQP - Good Quality Practice, GVP – Good Vigilance Practice) • Appointment of a MAH ‘Marketing Supervisor-General’(responsible person for quality control and market surveillance). Qualification requirements of Marketing Supervisor-General: depending on the product category (MHLW Ordinance)

  37. 2. Pharmaceutical Affairs Law (PAL) License (Registration) for Manufacture ‘License for Manufacture’ is required for all production sites(also abroad, with the exception of component suppliers) Depending on the category of the license, the building and it‘s equipment are subject to different requirements.- Manufacture license categories: Type No. 1 ‘Animal Origin Devices’ (PAL, Article 43) Type No. 2 ‘Sterile Devices’ Type No. 3 ‘Other than No.1 and No.2(Other general devices) Type No. 4 ‘License for Labeling, Packaging and storage - Foreign manufacturers do not obtain a „manufacture license“with other words: an „Accreditation“ of all production sites

  38. 2. Pharmaceutical Affairs Law (PAL) License (Registration) for Manufacture PAL:(License for Manufacture) Article 13 - The License has to be renewed every 5 years. - Building and equipment must comply with the standards given by MHLW Ordinance # 180 Article 13-2 Inspection and registration is done by Prefecture and PMDA (Pharmaceuticals and Medical Devices Agency). These organizations reserve the right to do an Inspection/Audit on-site.

  39. Domestic (License) Foreign Manufacturer (Accreditation) Category IVD PMDA PMDA Radioactive Prefecture PMDA Others Medical Device PMDA Cell/tissue derived PMDA Prefecture Others PMDA 2. Pharmaceutical Affairs Law (PAL) Requirements of License (Registration) for Manufacture - Inspection of Buildings and Facilities of Manufacturers: Building and equipment must comply with the standards given by MHLW Ordinance # 180 - Quality System Inspection (QMS Ordinance No.169) is required

  40. 2. Pharmaceutical Affairs Law (PAL) Accreditation of Foreign Manufacturer by PMDA - A person intending to manufacture in a foreign country drugs or medical devices etc. that are imported to Japan may be accredited by the Minister as a foreign manufacturer. - Accreditation is granted for each site according to the categories. - Accreditation shall be renewed every 5 years.

  41. 2. Pharmaceutical Affairs Law (PAL) Product Approval Procedure under PAL • Approval (Shōnin) of Medical Device by PMDA • Certification (Ninshō) of Medical Device by RCB (Registered Certification Body )

  42. Classification by PAL Class I Class II Class III Class IV General MD (Designated) Controlled MD Specially Controlled MD Product CertificationProduct Approval no requirements by RCB by MHLW (Application to PMDA) • RCB: Registered Certification Body • alltogether 14, out of that only 3 RCB accredited for all 400 product categories (> 700 products) • PMDA: Pharmaceuticals and Medical Devices Agency (Independent Agency of the MHLW) 2. Pharmaceutical Affairs Law (PAL) Product Approval/Certification System

  43. Applicant MAH Post Market Requirement Conformity (GVP) Quality Assurance Item Conformity （GQP) Registered Certification Body • Certification Applicant • Evidence for Criteria Conformity • Self Declaration of Criteria Conformity ②　Document Review ①　Certification Application Document evaluation based on individual conformity criteria of product ④　Certification (Product) • 　On-Site / Doc Audit for conformity to ordinance 169.Confirm evidence related to criteria conformity as needed Manufacturing Site （Manufacturer） Facility Structure Criteria Mfg Control / Quality Control （GMP/QMS) Audit accordance with ISO IEC 17021 ③　On-Site or Doc Audit ⑤　Follow-up Audit (After Certification) • 　Follow-up Audit related to Ordinance 169(GMP/QMS) Conformity once a year 2. Pharmaceutical Affairs Law (PAL) Certification Process by Third Party Certification (RCB) System

  44. 2. Pharmaceutical Affairs Law (PAL) License (Registration) for Manufacture Registration of the Production Site: Application: Attachments: • Name of the manufacturer • Address • Registration category • Attachment for buildings and equipment • Name & private address of the management representative • Name & address of the applicant (could be foreign manufacturer or MAH) • Overview/technical drawings of the buildings and the equipment • Resumee of the management representative • List of the manufactured products • Manufacturing process • Copies of existing licenses, approval or certificates

  45. 2. Pharmaceutical Affairs Law (PAL) How to put your products on the Japanese market Product Approval/Certification Steps for Foreign Manufacturers • Appointment of the Appointed/DesignatedMAH (DMAH) in Japan • Accreditation of the production facility by PMDA • Application for product approval (via DMAH or directly)a) Class II: to RCBb) Class III, IV: to PMDA • - RCB/PMDA reviews the product application documents and checks the QMS(GMP) compliance (on-site Audit or Document Review of manufacturing facilities)

  46. 2. Pharmaceutical Affairs Law (PAL) References Revision of the Pharmaceutical Affairs Regulations 2002 Edition by Pharmaceutical Affairs Study Group Yakuji Nippon Ltd. ISBN 4-8408-0726-4 • The Pharmaceutical Affairs Law • New Regulations Effective in 2005 - • Edited by The Japan Federation of Medical Devices Associations • Yakuji Nippon Ltd. (www.yakuji.co.jp/e/publications/ ) • ISBN 4-8408-0773-6

  47. 3. Test and Certification for Telecommunication Products

  48. 3. Test and Certification for Telecommunication Products Regulatory Scheme in Japan

  49. 3. Test and Certification for Telecommunication Products Certification Scheme in Japan Wired Products Home Electric Radio Products • Telephone • FAX • PBX • ISDN Terminal • PC etc. • Bluetooth • Wi-Fi • ZigBee • Low Power security etc. • Cellular Phone • Cordless Telephone • Wireless LAN • AC Adapter　　　etc. • Pump etc. DENAN Law (Safety) Telecommunication Business Law Radio Law

  50. By CB By SDOC ①Test Certification ②Type Approval Applicant CB Investigation Test and Document Judgment Test and Document Judgment Test and Document Verification Preservation Product Certificate Type Approval Certificate Indication Design Conformity Design Conformity MIC Data Preservation Data Preservation Bring to Market Publication Bring to Market Indication Indication Effectiveness of Certification and Obligation 3. Test and Certification for Telecommunication Products Flow of Radio/Telecom Products Certification by CB and SDOC

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