主要の医療用具規制の要約 ・欧州連合 (EU) 〇米 国 (USA)
Contents
1. FD amp CAct 8 706 Restricted Deyices FD amp CAct 820 e 2 a Genera1 Device Labeling 21CFRPart801 b InVitro Diagnostic Medical Devices 21CFRPart809 c Investigationa1 Device Exempt2. 1 concept 3 Bio Compatibi1ity 12 Custom Made Medica1 Deyice 1 2 WW
3. 5 7 Records and reports 1 adatterated misbranded 2 Post market Snrvei11ance Contro1 Medica1 Device Reporting Regulation MDR Adyerse effect 5 8 Restricted deyices 1 2
4. 5 FDA 0rder 90 6 FDA 0rder PMN Pre market Approva1 7 1 HE 1976 5 28 5 5 Banned device 1 FD amp C Act 516
5. 4 4 1 1 Vulnerability 4 1 1 Low Risk 2 Ha Medium Risk 3 Tb Medium Risk 4 High Risk 2 I 2 Ha a
6. Genera1 Specia1 Pre market Control Control Aroval 1 E 1 2 Low Risk Genera1Contro1 Medium Risk Genera1 Control SpecialControl High Risk Genera1Contro1 a ill nk 5 Genera1 Contro1 5 1 5 9 9
7. Medical Device Listing Listing b Listing Form2892 EDA Generic category FDA 1700 Generic category CFR Tit1e21 Parts862 892 c Form2892 Product Code Classification Database Generic category Form d Listing e Listing Form 2892
8. 21CFR 2 PMA 30 8 Tnvestigationa1 Device Exemption IDE Regulation
9. 5 4 Pre market Notification PMN 1 Pre market Approva1 2 90 3 PMN Pre market Approva1 Substantially Equivalent PMRY 4 FDA
10. 6 5 9 Good Manufacturing Practices GMP Qua1ity System Regulation QS 6 Specia1 Contro1 Q 2 General Contro1 7 Pre market Approva1 PMA 1 21CFR Part814 1976 5 28
11. 1 3 B R CE USA 1 1 1976 5 28 2 Food Drugs and Cosmetic Act FD amp C Act 3 Rules and Regulations 21CFR Part 2 5 3 PMN Pre Market Notification PMA Pre Market Anproya1 4
12. 2 5 6 Notification and repair reptacement and refund G ES 2 3 SA
13. 5 1 Adurlteration ED amp ECAct Ch Y Sub Ch A 8 501 1 Adulterated Device Good Manufacturing Practices GMP TIDE Tnvestigationa Device Exemption 5 2 Misbranding FD amp CAct Ch Y Snb Ch A 8 502 1
14. 6 1 E R BE R N B 2 7 EU 4 R 5 8 CE 1 CE 5mm
15. Non invasive C Active Non Active 5 1 T MW 8 8 Fu1t Quality System EN46001 N B N B b N B c tV N B 9 V N46002 N B e VH EN46003 N B VH 11 I I I Ia Hb E HH HL hl WV Y VI WW VWW Custom Made Medical Device
16. 8 Vigilance System 9 10 1i 11 12 EU Authorized Representative A R 13 CE 14 Hea1th Insurance Orga
17. 2 Custom Made Medica1 Device CE 9 Vigi1ance System 1 4 R 10 1 1 A R 2 A R _ 11
18. N B Hb 4 2 1 9 18 a Transient use 60 Short term ruse 30 Long term use 30 b invasive
19. E 8 MI EVE EU USA EU soos os 93 42 EEC 1 1 Active TLmplantab1e Medica1 Devices Directive 90 358 EBC 2 Medical Devices Directive 93 42 EEC 3 In vitro Diagnostic Medical Devices Directive 98 79 EC 2 93 42 1 3 1 9 3 11 5 6 EU 5 7 CE
20. ions 21CFRPart812 d Good Manufacturing Practices 21CFRPart820 e Genera1 Electronic Products 21CFRPart1010 5 3 Device registration and listing FDA 1 Estab1ishmentRegistration 30 Form2981 Initial Registration 30 2 Medical Device Listing a
21. nization 3 Gi Reqnirements E R 1 1 B R 2 EN1441 IS014971 2000 JIS T 14971 2003 E R 3 E R ER
Download Pdf Manuals
Related Search