薬事法改正に向けた医療機器業界からの要望書
Contents
1.2.
3.
4.
5. 7 7
6. 43 23 7 6
7. 6
8. 63 63
9. 2 A 3
10. PNDA 2
11. 43 23 6 TE
12. 8 3 Fd 23 7 6 I 14 9 QMS QMS
13. 2 IV VI 7
14. 8
15. HH VI NS CT MR 85 4 i ROHS D 3 1
16. VI B 1 22 4 28
17. 3 3 V VI 2
18. 5 QMS E
19. VI 64 1 22 6 55 64
20. VI 1 IT
21. QOL G 1
22. 43 23 7 6
23. 1 2
24. JIS QMS JIS IS0 IEC
25. 43 23 7 6
26. 3 GMDN
27. QMS GQP QMS 3 QMS
28. A 1 2
29. 177 PMDA H 14 14 1
30. 1 V V
31. MI
32. STED C 1
33. MDA 3 7 E 13 GMP QMS 13
34. IT 6 7
35. GMP QMS IV 23 2 a 4 7 1 PMDA
36. F 1 1 2
37. SO JIS 0307 5 7 2 63 2 PMDA IT
38. GCP 18 1 16 1116002 23 2 1 2
39. QMS j QMS 3 QMS GMP QMS QMS QMS
40. QMS GHTF 14 9
41. RS EN 4 3 IV 23 2 5 1 2 3 V 63 Sb 5 1 2 ND nw tO MM 4 woo RE ERE 6 1 WI 6 1 2 SS
42. QMS QMS 1S013485 QMS IS013485 J S Q 13485 13013485 0QMNS QMS QMS 14 5 QNS GLP GCP
43. 43 23 7 6
44. QMS 2 7 23 2 QMS 14 6 QMS PMDA 23 2 1S013485
45. 1 QMS M amp A 2
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