ASEAN 医療機器指令の概要と各国の 対応状況向調査 - JETRO

1 ASEAN .. 2022 3 .. Copyright(C) 2022 JETRO . All right reserved.. ASEAN ASEAN ASEAN Medical Device Directive AMDD 2014 11 21 ASEAN10 .. AMDD ASEAN .. AMDD . 2022 3 ASEAN 6 4 . AMDD . 2 .. AMDD AMDD . ASEAN .. ( common Submission Dossier template . CSDT) . AMDD .. ASEAN AMDD . ASEAN 6 AMDD . 2022 3 .. 2022 3 .. Copyright(C) 2022 JETRO . All right reserved..0. I. AMDD ..1. 1. AMDD ..1. 2. AMDD ..2. II. AMDD ..4. 1..4. a..4. b..5. c..5. d..10. 2..10. 3..11.. CSDT ..13.. ASEAN 6 AMDD ..15. 1..17. a..17. b..17. c..18. d..21. 2..24. a..24. b..24. c..25. d..27. 3..30. a..30. b..30. c..30. d. AMDD ..33. 4..36. a..36. b..36. c..37. 5..41. a..41. Copyright(C) 2022 JETRO . All right reserved. b. AMDD ..41. 6..43. a..43. b. AMDD ..43. V..45. 1..45. 2..46. a..46. b..47. c..47. d. CSDT ..48.. SaMD ..49. Copyright(C) 2022 JETRO . All right reserved. I. AMDD . 1. AMDD . AMDD 2014 11 21 ASEAN10 . AMDD. 2015 1 . AMDD.

2 AMDD AMDD . AMDD ASEAN ASEAN ASEAN . Economic Community AEC AEC 2015 . ASEAN . AMDD . 2014 . AMDD 2014 ASEAN ASEAN Medical Device Committee AMDC . AMDD 1 . (1) ASEAN .. (2) .. (3) .. AMDD EU . Global Harmonization Task Force . GHTF) . GHTF 2012 GHTF 2011 . International Medical Device Regulators Forum IMDRF . GHTF . 1. Copyright(C) 2022 JETRO . All right reserved. 2. AMDD . AMDD AMDD Article Annex .. AMDD AMDD . 17 .. - AMDD .. 1 13 . 2 14 . 3 15 .. 4 16 . 5 17 . 6 18 . 7 19 .. 8 20 . 9 21 . 10 22 . 11 23 . 12 PMAS 24 . -2 AMDD .. 1 . 2 . 3 IVD . 4 ASEAN CSDT . 5 (PMAS) . 6 . 7 . 8 . 2. Copyright(C) 2022 JETRO . All right reserved. AMDD .. ASEAN Medical Device Directive, AMDD. ( ). 3. Copyright(C) 2022 JETRO . All right reserved. II. AMDD . 1.. ASEAN CSDT . AMDD . a.. AMDD IVD .. AMDD .. IVD .. 2 AMDD accessories .. instrument apparatus implement machine . appliance material .. a . b . c . d.

3 E . f . g .. IVD .. 4. Copyright(C) 2022 JETRO . All right reserved.. b.. 3 . PMDA 2 .. c.. 4 4 . A . B . C D. IVD IVD .. AMDD . A B . C D . ASEAN .. 5. Copyright(C) 2022 JETRO . All right reserved. c-1.. 4 16 .. 4 non-invasive invasive . active additional rules . 16 16. 3 .. AMDD GHTF . AMDD . AMDD .. -1 . non-invasive . 1 . A-C .. A-C .. B-C .. 1 3 A .. invasive .. A . A-C .. A-D . 6. Copyright(C) 2022 JETRO . All right reserved.. A-D .. B-D . active .. B-C .. A-C .. B-C . 1 3 A . additional rule .. D .. A D .. B C .. C D . AMDD . Health Sciences Authority HSA 4 .. -2 .. A . B . C . D . 7. Copyright(C) 2022 JETRO . All right reserved. c-2. IVD . 7 . IVD . AMDD 4 . AMDD AMDD .. -3 IVD . IVD . D .. C ABO A ABO1 B. ABO2 AB ABO3 Rh RH1 D RH2 C RH3 E . RH4 c RH5 e Kel1 K JK1. Jka JK2 Jkb FY1 Fya FY2 Fyb . D . C .. CMV .. 8. Copyright(C) 2022 JETRO . All right reserved.. CMV HSV .. HCV HIV HIV HCV.

4 C .. B . near-patient testing . C .. A .. 1 5 B . B .. AMDD IVD . 9. Copyright(C) 2022 JETRO . All right reserved. -4 IVD .. A .. B . IgE E .. C . HLA D .. D HIV, HCV, HBV, HTLV . d.. d-1.. 8 .. ASEAN common Submission Dossier template : CSDT . 4 . Post Marketing Alerts System: PMAS . 5 . Declaration of Conformity: DoC 6 . CSDT DoC .. CSDT . PMAS . CSDT . d-2.. CSDT . 10 . 7 .. 2.. 7 .. 10. Copyright(C) 2022 JETRO . All right reserved. 3.. 11 1 .. 11 . 1 .. 12 .. PMDA 2 .. ASEAN .. Field Safety Corrective Action FSCA .. 11. Copyright(C) 2022 JETRO . All right reserved.. ASEAN Medical Device Directive, AMDD. ( ). 2. PMDA . ( ). 3. PMDA .. ( ). 4. 2010 . ( ). 12. Copyright(C) 2022 JETRO . All right reserved.. CSDT . CSDT Executive Summary .. GHTF .. CSDT .. -1 CSDT . 3. Executive Summary (a) CSDT . (b) . (c) . (d) . (e) . (f) / .. 13. Copyright(C) 2022 JETRO . All right reserved.. ASEAN Medical Device Directive, AMDD.

5 ( ). 14. Copyright(C) 2022 JETRO . All right reserved.. ASEAN 6 AMDD . AMDD AMDD . CSDT 2022. 3 ASEAN 6 4 . AMDD CSDT 2022 . 1 AMDD 1 2023 CSDT. IVD AMDD . CSDT 2019 4 2023 3 . IVD 2022 1 . AMDD .. AMDD .. ASEAN . AMDD . AMDD .. 1 . AMDD .. AMDD A . A CSDT.. 15. Copyright(C) 2022 JETRO . All right reserved.. 16. Copyright(C) 2022 JETRO . All right reserved. 1.. Dealer's License . A . registrant . Medical Device Information and Communication System ( MEDICS) .. a.. Health Products (Medical Devices) Regulations 2010 . (HSA) . b.. Dealer's License . Manufacturer's License .. Importer's License . Wholesaler's License . 3 .. QMS QMS . GDPMDS SS620 GDPMDS Singapore Accreditation Council SAC SAC . d.. Guidance on Licensing of Manufacturers Importers and Wholesalers of MD .. 17. Copyright(C) 2022 JETRO . All right reserved. -1 QMS .. Manufacturer's License Importer's License Wholesaler's License . ISO13485 ISO13485 ISO13485.

6 GDPMDS GDPMDS. * 1) A .. * 2) A . A .. * 3) 12 . c.. registrant . (ACRA) .. c-1.. A . MEDICS the Class A Exemption List . GN-22: Guidance for Dealers on Class A Medical Devices Exempted from Product Registration . 18. Copyright(C) 2022 JETRO . All right reserved.. c-2.. 1 . 1 . 3 .. GN- Guidance on the Risk Classification of General Medical Devices GN-14-R2 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices .. -2 .. 2 .. IVD .. IVD . A B . c-3. B, C, D . MEDICS CSDT . B C D HSA .. GHTF . GHTF TGA (HC) (US FDA) (EU) .. 19. Copyright(C) 2022 JETRO . All right reserved. HSA . GN-15: Guidance on Medical Device Product Registration .. GHTF 1 Abridged evaluation route . -3 HAS Abridged evaluation route . Class Class B. C D. CSDT . Letter of Authorization .. CSDT. Executive summary .. Summary Summary .. QMS . ISO13485 US FDA Quality System Regulations QMS . 169 1 . - . c-4.

7 HSA . HSA .. 20. Copyright(C) 2022 JETRO . All right reserved.. Full route Abridged route HSA .. -4 Abridged / Full route .. Abridged route 100 160 220 . Full route 160 220 310 . * 1) . * 2) 2022 20% . d.. SAC . 2022 3 . SAC .. -5 SAC .. Advanced Certification (Singapore) Pte Ltd A-Europe Certification Pte Ltd BSI Group Pte Ltd Bureau Veritas Quality Assurance Pte Ltd Certfication Partner Global (Singapore) Pte Ltd DAS Certification Singapore Pte Ltd DNV Business Assurance Pte Ltd Management System EHS Universal Certification EPI Certification Pte Ltd EQA IMS Certification Pte Ltd Ernst & YoungCertifyPoint Guardian Independent Certification Pte Ltd ICR Singapore Certification Pte Ltd ISOCERT Pte Ltd KW Certification Pte Ltd Lloyd's Register Quality Assurance Limited 21. Copyright(C) 2022 JETRO . All right reserved. QAI Certification Pte Ltd SC2 Pte Ltd Setsco Services Pte Ltd SGS International Certification Services Pte Ltd Singapore Test Services Pte Ltd SOCOTEC Certification Singapore Pte Ltd Transpacific Certification s (Singapore) Pte.

8 Ltd. T V Rheinland Singapore Pte Ltd T V S D PSB Pte Ltd URS Far East Pte Ltd Admaterials Technologies Pte Ltd CAST Laboratories Pte Ltd Centre Testing International Pte Ltd Product Certification Control Union Singapore Pte Ltd Double Helix Tracking Technologies Pte. Ltd. Guardian Independent Certification Pte Ltd Intertek Testing Services (Singapore) Pte Ltd Majlis Ugama Islam Singaura Setsco Services Pte Ltd SGS Testing & Control Services Singapore Pte Ltd Singapore Environmental Council Singapore Laboratory Services Pte Ltd Singapore Test Lab Pte Ltd Product Certification Singapore Test Services Pte Ltd SOCOTEC Certification Singapore Pte Ltd T V S D PSB Pte Ltd - Product Listing Scheme (PLS). T V S D PSB Pte Ltd - Ready-Mixed Concrete (RMC) Certification Scheme UL International-Singapore Pte Ltd UK Certification Authority for Reinforcing Steels CCTP Certified Counter Terrorism Board Institute of Management Consultants (Singapore).

9 Non-Destructive Testing Society (Singapore). Personal Certification Singapore Business Advisors and Consultants Council Limited Singapore Rope Access Association Limited T V S D PSB Pte Ltd 22. Copyright(C) 2022 JETRO . All right reserved.. HSA HP ( ). 2010 .. 23. Copyright(C) 2022 JETRO . All right reserved. 2.. Establishment License .. Authorized Representative . Medical Device Centralized Online Application System . MeDC@St .. a.. 2012 Act 737 . Medical Device Authority MDA . b.. Establishment License . Manufacturer . Authorized Representatives AR . Importer .. Distributor 4 .. AR . AR .. AR AR . QMS . QMS QMS MDA . Conformity Assessment Body CAB CAB d.. MDA How to Apply for Establishment Licence . ( ) . MDA/GD/0027 Licensing for establishment .. 24. Copyright(C) 2022 JETRO . All right reserved. -6 QMS .. Manufacturer's License AR, Importer, Distributor's license . ISO13485 GDPMD. * 1) 12.

10 C.. AR . CAB . A CAB Medical Device (Exception). Order 2016 MDA . 5 .. c-1.. 1. c-2 . Guidance Document 25. Copyright(C) 2022 JETRO . All right reserved. on Product Grouping . ( . c-2. CAB . CAB MDA/GD/0031 Medical Device Guidance Document Conformity assessment for medical device . ( . QMS. PMS System CSDT . DoC . B C D GHTF . GHTF TGA . (HC) (US. FDA) (EU) Circular Letter of the Medical Device Authority Year 2014: Conformity Assessment Procedures for Medical Device Approved By Recognised Countries . ( ). c-3.. AR MeDC@St CSDT . Guidelines on How to Apply for Medical Device Registration Under Medical Device Act 2012 (Act 737).. (IVD . IVD . IVD . 26. Copyright(C) 2022 JETRO . All right reserved. -7 MDA IVD .. - . - A . - . - . - . - CSDT . - CSDT . - on the active ingredient/poison/drug . - CAB . - .. A . CSDT CSDT .. DoC .. d.. MDA CAB . 2022 3 . CAB . MD 0101 Guidelines on How to Apply for Medical Device Registration Under Medical Device Act 2012 (Act 737).)))