海外の薬事制度について
Contents
1. 14 510 k 3 PMA HI De Novo Classification 510 k 1 1 310 k IVD 200 510 k 4 I 510 k2. MDR MDUFMA 2002 Medical Devices User Fee and Modernization Act PMA 510 k FDA PMA 10 3 I General Control I Special Control PMA performance standard 10 k PMA S10 k PMA FD amp CA S 510 k FD amp CA 8 515
3. FDA FY2004 25 FDA 30 FDA _ S10 k Special 510 k QSR 30 http Www fda qov cdrh devadvice 3144 html 10 k Traditonal 510 k 510 k Abbreviated 510 k
4. Patient Registry 41 Patient Registry HI FDA Tracking Order 12 4 http www fda qov cdrh comp guidance 169 html 21 CFR 821 SOP 21 3 e 90 385 EEC Active Implantable Medical Devices Directive AIMDD e 93 42 EEC Medical Devices Directive 98 79 EC MDD In Vitro Diagnostic Medical Devices Directive IVDMDD MDD 2000 70 EC 2003 12 EC 2003 32 EC 2005
5. 170 1997 FDA FDA L 510 k 60 1976 Pre Amendments Class IM 510 k 16 510 k 3 FDA 510 k Traditional 510 k S10 k 10 k S10 k 510 1997 FDA 1998 3 New 510 k Paradiszm 310 k Special 510 k 30 510 k Abbreviated 510 k FDA FDA
6. 510 k 510 k 6 2002 S10 k 4 158 3 326 FY2007 S10 k Traditional Special Abbreviated S10 k FY2004 3110 74 100 510 k 720 30 40 510 k 110 86 119 s S10 k 1997 EFDA FDA I T 1998 FDA
7. Tradinonal 510 k http Www fda qov cdrh devadvice 3145 html 10 k Traditional 510 k Traditional 510 k Form FDA 3514 S10 k S10 k Ne o Establishment Registr
8. Class I Class Ia Ib MDD 1 1 Class III 2 3 4 5 28 MDD 2 6 7 8 9
9. FDA QSR ISO 9001 1994 FDA ISO 13485 2003 Device Master Record DMR Device History Record DHR
10. Imitial Report Follow up Report 1 Final Report Final Report 64 32 MDD Annex II point 3 1 indent 7 Annex Post Market Surveillance Post Market Surveillance
11. 10 MDD 3 11 5 17 QA DMR 29 MDD 4 18 19 20 1 HI a 21
12. MDR MedWatch Form FDA 3500A MEDWATCH Form FDA 3500A Device Code Patient Code MedWatch MEDWATCH Medical Device Reporting Code Instructions http www fda gov cdrh mdr 373 html 4 MDR Baseline Report Form FDA 3417 Form FDA 3417 S10 k PMA
13. Removal MDR FDA FDA 21 CFR Part 810 Medical Device Recall Authority 21 CFR Part 822 Postmarket Surveillance PMS I 1 FDA 39 FDA
14. MDD IVDMDD AIMDD CE Marking 4 CE Marking CE Markins 27 MDD MDD Annex I RUV ISO 13485 2003 Class Ta Tb Class Class I
15. 1 MDD 22 23 24 25 26 27 Class II 5 15 60 30 1 e Vigilance System 2
16. 2008 1 22 30 14 H HL IV 1 2 FDA CDRH 300 Third Party 11 932I 10 12 510 k I 3 4 Competent Authority 27 EU 4 EFTA Notified Body 79 I Ia Hb II Design Dossier Technical File Ia Ib 374 PMA 281 600 107 000 Design Dossier 510 k 4 158 3 326 V 3 II Post Market Surveillance II Post Market Clinical Follow up 3 US Agent
17. FDA 60 MDR MDR http www fda qov cdrh mdrfile html http7 www accessdata fda 9oV scripts cdrh cfdocs cfmdr search CFM 36 21 CFR Part 806 Medical Devices Reports of Corrections and Removals Correction Removal 10 FDA 21 CFR 7 3 m I ZI IL FDA 37 IE Correction
18. Food and Drug Act FD amp CA MDAA 1976 Medical Device Amendments Act 5S10 k PMA EEE GMP MDR PMS 1 General Control I Performance Standard PMA SMDA 1990 Safe Medical Devices Act I Special Control S10 k SE QSR EFDA FDAMA 1997 Food and Drug Administration Modernization Act FDA
19. Post Market Clinical Follow up PMCE PMCF GUIDELINES ON POST MARKET CLINICAL FOLLOW UP May 2004 MEDDEV 2 12 2 66
20. Quality System Record QSR Design History File DHF Complaint File QSIT FDA nspection Guide to Inspections of Quality Systems Ouality System Inspection Technique QSIT http www fda gov ora inspect _ref igs qsit QSITGUIDE PDF QSIT 4 GHTF 7 I 1 21 CFR Part 803 Medical Device Reporting MDR
21. Authorised Representative 0 QMS 15 MDR 30 10 Corrections amp Removals Device Tracking 510 k STED FDA 1 5 Harmonization By Doing Quality System EN ISO 13485 2003 Regulation QSR Manufacturer s Incident Report 10 Field Safety Corrective Action 4 Ia Ib FD amp CA 4 MDAA 1976 SMDA 1990 FDA FDAMA 1997 MDUFMA 2002 FD amp CA Federal Food Drug and Cosmetic Act 1938 6 25 1906
22. S10 k 310 k I EFDA http Www fda qov cdrh reglistpage html 30 Form FDA 2892 http Www accessdata fda 9oV scripts cdrh cfdocs cfRL Pri ntForm2892 cfm 25 1 1978 GMP SMDA 1983 6 44 90 1996 FDA GMP 21 CER Part 820 Quality System Regulation QSR 2
23. 10 FDA 10 1 Form FDA 3419 FDA Annual report Medical Device Reporting Annual User Facility Report FDA Form 3419 33 2 30 FDA FDA 34 3
24. S10 PMA FDA FDA 36 FDA FDA 60 FDA 40 20 21 CFR Part 821 Medical Device Tracking Requirements 1
25. PremarketNotificaiion Pemarket Approval Submission Application PMA SE 3 4 10 12 Clearance Approval PMS 510 k 1 pemarket notification FD amp CA 510 k http www fda dov opacomlaws fdcactfdcact5a htm 90 FDA 510 k 21 CFR Part 807 Subpart E Premarket Notification Procedures 510 k 2 FDA Substantial Equivalence SE
26. MDD MDD 7 MDD ANALYSE DEVICE Structure INTENDED PURPOSE CLASSIFY z DEVICES I I I eIn vitro Tests In vivo Tests CLASSI CLASSIla CLASSIlb CLASS III CLINICAL EVALUATION DETERMINE CONFORMITY TECHNICAL DOSSIER p PRODUCTION EC DECLARATION OF CONFORMITY M NATIONAL MDD TRANSPOSITIONS Labelling COUN S TRY ISSUE Registration 30 EEA MEMBER STATES SWITZERLAND MDD CLASS CLASS lla CLASS llb CLASS III Manufacture Til Third party intervention Design dossier examination MDD The PLAYERS Manufacturer Registrations e Inspection e Surveillance Certification l Vigilance Enforcement Notified _ Competent Body Authority Accreditation e Consultation e Liaise other NB s Surveillance NB MED
27. Vigilance System GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM April 2007 MEDDEV 2 12 1 rev5 lt 2007 gt Vigilance Incident Reporting 62 31 3 Imcident Near Incident 10 30 Near Incident Malfunction Initial Report Follow up Report Final Report 63 4
28. 50 EC Devices Incorporating Human Blood Derivatives Reclassification of Breast Implants Class Ilb III Tissues of Animal Origin Reclassification of Hip Knee and Shoulder Joint Replacements Class Hb gt HI 22 MDD 1 Directive 2007 47 EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90 385 EEC on the approximation of the laws of the Member States relating to active implantable medical devices Council Directive 93 42 EEC concerning medical devices and Directive 98 8 EC concerning the placing of biocidal products on the market Official Journal L 247 21 09 2007 P 0021 0055 MDD 2 MDD AIMDD lt 2007 9 Directive 2007 47 EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 2007 9 21 Official Journal MDD AIMDD 2010 3 21 2008 12 21 Directive 98 8 EC IVDMDD IVDMDD 23 MDD 3 MDD
29. QSR ISO 13485 1996 ISO 9001 1994 ISO 13485 2003 QSR QSR QSR 3 QSR 1 QSR I I I 2002 MDUFMA FDA
30. ation 21 CFR Part 807 30 FDA FDA http www fda gov cdrh reglistpage html Form FDA 2891 http Www accessdata fda doV scripts cdrh cfdocs cfRL Pr intForm2891 cfm 23 United States Agent 2002 2 11 United States Agent Form FDA 2891 US Agent FDA FDA US Asent http7 www accessdata fda 9oV scripts cdrh cfdocs cfUSa genYsearch cfm Device Listing FDA 21 CFR Part 807
31. lt Enforcement e Liaise other CA s EC Commission MEDDEV 50 25 CE Marking 1 e CE Marking CE Conformit Europeene European Conformity EC Mark 1993 Directive 93 68 BEBC CE Markins CE Marking 2 CE Marking EU CE Mark CE Marking CE Marking EU EFTA 31 EU EFTA European Economic Area BEA 26 CE Markins 3 CE Marking CE Markins
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