日本医療機器産業連合会提出要望書（PDF:895KB）
Contents
1.2.
3. I VI
4. 1 7 A 1
5. ROR UTE Ic FRR aR 23 7 6 EX amp DC Y E 1 TI 14 ee ee ee ee are 2 HAEDO VERBO DARE EU QMS OMS
6. E GMDN IM
7. W V
8. v 63 1 63 IS0 JIS 10300 5 7
9. PMDA 2 QMS
10. 5 6
11. GHTF 14 9 PIDA
12. B 1 22 4 28 1 2
13. 2 A 3 5 QM
14. IT IT 6 7
15. QMS JIS IS0 JBC 3
16. 4 V V 2 ASTHMA ew CRIME ACRES LOTT QOL Cy RE ORIER A BT EKD LOM EACLE TER ERBE DERE BOLT ST CeEALET G 1 AEREA RO REA O OT
17. RB 3 STED C SECS SR 1
18. PMDA T 14 14 1
19. MBEECSEODCHSTEDS 2 3
20. 2 W V 7
21. NS OMBRBCSD TE FRENDS DIED CE GCP 18 11 A 16 CERES 1116002 5 23 2 2
22. TRE
23. 1 2 3
24. O 7 de 2 O 8 GLP GCP o 9 7921 10 ll
25. I DD 6 1 7
26. RE 3 7 MM 13 GMP QMS 13 1 QMS
27. 2 63 2 ORELBNT RANGER ONCE TOETM PMDA 1T Vi 64 1
28. HEROE TE M amp A 2 PR A QMS
29. 2 VD PMDA gt 2 QMS 8
30. 8 SEZLKT E RESUMO OMB RS ES 1 2739 EL AOR EMEC SE
31. 2 1 23 RO 2 QMS 14 6 QMS PMDA 23 RO 2 15013485 0NS QMS 15013485
32. 85 REE 4 7 D 1
33. 9 GLP Good Laboratory Practice 10 GCP Good Clinical Practice 3 43 33 6 R
34. GQP QMS 3 QMS GMP US IV
35. QMS 12 ISO 1 PMDA 2 QMS Quality Management System Global Harmonization Task Force 4 QMS IS013485 2003 6 GMP Good Manufacturing Practice 7 150 Internalional Organization For Standardization 8 IEC Intermational Electrotechnical Commission
36. JIS ISO TEC O J 6 1 Ho RRSIBIC Ss WHER O REL RRO Ae DS 3
37. QMS 18013485 IIS Q 13485 S013485 QWS QMS QNS 14 5 QMS GLP GCP QMS
38. 2 3 4
39. 22 6 55 64 T Mm 1
40. TSO18485 O 4 M amp A 5 GIS DATE QMS
41. 3 3 23 7 6 1
42. 23 RO 2 41 1 10 PMDA 2 7S
43. I 19 ee ee ee ee oe SS re 4 1 HENELZORENIET RR ATI 2 A A ee 3 e V 23 ED 2 a ee ne ten je 5 1 2 3 V 63 5 1 2 Qoo oo a VI 64 6 1 W 6 1 2 Gl IM
44. QMS 3 QMS GMP QMS OMS QMS QMS MAR
45. GHTF s O 3 QMS ISO018485 GMP s 1 ae QMS QMS 2 QMS
46. S E I w v
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