アジアにおける医療機器規制 - アジアデンタルフォーラム
Contents
1. 4 2 1 4 2 2 4 2 3 4 2 4 4 2 6 4 3 1 ains E EAT T m 4 3 1 1 7312 4 3 2 4 3 2 1 4 4 1 4 4 2 4 5 1 4 6 1 YOSHIDA PMAS Post Marketing Alert System e Importation and or distribution records Complaint records Adverse event AE reporting criteria and reporting format e Field Safety Corrective Action FSCA reporting format YOSHIDA eDoC Product Owner We hereby declare that the below mentioned devices have been classified according to the classification rules and conform to the Essential Principle2. I SOPs htto www fda gov tw EN law aspx 5 Q UEC ISO A B9 JUN RABA TORATE re Q Q JIS A JIS IEC ISO Q A YES 6 FSC Free Sales Certificate OMETA ISO 13485 Certificate Notarization gt asof 2o1403 15 ASEAN HP http www aseansec org AHWP HP http www ahwnp nfo IMDRF HP http www imdrf org ISO HP http www iso org iso home IEC HP http wwwjec ch OMETA HP http www ome
3. 2014 2014 03 15 Disclaimen Cd ASEAN AMDD 1 ASEAN Association of Southeast Asian Nations ASEAN Association of Southeast Asian Nations ASEAN 1967 8 8 cundis 28 imum 23 1967 8 8 1997 7 23 1984 1 8 1999 4 30 http www mofa g
4. MDA Medical Device Authority http www mdb gov my mdb index php RDI we GHTF A ZD 4 CSDT DoC MeDCaSt Web Z 4 CFDA China FDA X 8 CCC L IIZ8 2013 4 http eng sfda gov cn WSO3 CLO755 4 DHE MFDS Ministry of Food and Drug Safety 1 4 KGMP http www mfds go kr eng index do 4 TFDA Taiwan FDA
5. 1 2 3 Executive Summary CSDT 4 CSDT 4 1 4 1 1 4 2 4 2 1 4 2 2 4 2 3 4 2 4 4 2 5 4 2 6 CSDT 4 CSDT 4 3 4 3 1 4 3 1 1 4 3 1 2 4 3 2 Clinical Evidence 4 3 2 1 CSDT 4 CSDT 4 4 4 4 1 4 4 2 4 5 4 5 1 4 6 4 6 1 STED vs CSDT STED CSDT ASEAN
6. GENERAL PROVISIONS ARTICLE 2 DEFINITIONS AND SCOPE ARTICLE 3 ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICE ARTICLE 4 ARTICLE 5 CLASSIFICATION OF MEDICAL DEVICES CONFORMITY ASSESSMENT OF MEDICAL DEVICES ARTICLE 6 REGSTRATION AND PLACEMENT ON THE MARKET ARTICLE 7 LICENSING OF PERSONS RESPONSIBLE FOR PLACING MEDICAL DEVICES ON THE MARKETS OF MEMBER STATES YOSHIDA AMDD ver 14 ARTICLE 8 TECHNICAL DOCUMENTS FOR MEDICAL DEVICES ARTICLE 9 REFERENCE TO STANDARDS AND RELEVANT DOCUMENTS ARTICLE 10 LABELLING ARTICLE 1 1 ARTICLE 12 MEDICAL DEVICE CLAIMS POST MARKE TING ALERT SYSTEM PMAS ARTICLE 13 CLINICAL INVESTIGATION ARTICLE 14 INSTITUTIONAL ARRANGEMENTS YOSHIDA AMDD Ver 140 ARTICLE 15 SAFEGUARD CLAUSES ARTICLE 16 ARTICLE 17 CONFIDENTIALITY SPECIAL CASES ARTICLE 18 IMPLEMENTATION ARTICLE 19 ARTICLE 20 DISPUTE SETTLEMENT FINAL PROVISIONS YOSHIDA AMDD Ver 14 ANNEX 1 ANNEX 2 ANNEX 3 Essential Principles of Safety and Performance of Medical Devices Risk Classification Rules for Medical Devices other than IVD Medical Devices Risk Classification Rules for IVD Medical Devices ANNEX 4 ASEAN Common Submission Dossier Template ANNEX 5 Post Marketing Alert System PMAS Re
7. auirements YOSHIDA AMDD ver 140 Components Elements of a Product Owner s or ANNEX 6 Physical Manufacturer s Declaration of Conformity DOC ANNEX 7 Labelling Requirements ANNEX 8 Clinical Investigation YOSHIDA Article 1 Genera Provisions 1 AMDD 2 3 D t nal YOSHIDA AMDD AMDD QUSS Article 8 Technical Documents CSDT Common Submission Dossier Templates ANNEX4 PMAS Post Marketing Alerts System ANNEX5 DoC Declaration of Conformity ANNEXG CSDT
8. ojp mofaj area asean ASEAN 2003 ASEAIN 2007 2015 ASEAN 20095 ASEAN 2009 20150 ASEAN APSO ASEAN AEC ASEAN ACO http www metigojp policy trade_policy east_asia activity aseanhtml ASEAN AEC AFTA ASEAN 201O CLMV 201 ASEAN AEC AEC amp 1 12 2 3 4 http www meti go jo policy trade policy east asia activity asean html YOSHIDA 2 AMDD ASEAN Medical Device Directive AMDD ASEAN CSDT BH ACCSQ ASEAN Consultative Committee for Standard Quality TEIE PESARA B MDPWG Medical Device Product WG WG YOSHIDA AMDD Ver 120 ARTICLE 1
9. s for Safety and Performance as laid out in the Authorized Representative Manufacturing Site gt Medical Device s gt Risk Classification Class B rule XX Quality Management System Certificate lt gt Standards Applied This declaration of conformity is valid from Day Month Year Authorized Signatory Position Name _ Date YOSHIDA 3 HPA Health Products Act 2007 HSA Health Sciences Authority http www hsa gov sg publish hsaportal en home htmlZ page tab 1 YOSHIDA 12 30 I GHTF A AD 4 CSDT DoC e MEDICS Web 3 MDA Medical Device Act 201 2 Act 737 e MDR Medical Device Regulations 2012 MDR20O1 2 e MDAA Medical Device Authority Act 2012 Act 738
10. ta or jo adfinfo feelocnne jp
Download Pdf Manuals
Related Search