平成24年度 分担研究報告書 海外における医療機器の添付文書の規制
Contents
1. Us ll 9 pil SEI2. gt Device Labeling Guidance G91 1 i i i 1
3. 5 GHTTF D EE Label Label
4. GHTTF B 1 Labeling Regulatory Requirements for Medical Devices HHS Publication 89 4203 U S Department of Health and Human Service August 1989 http www fda gov downloads Medical Devices DeviceRegulationandGuidance G uidanceDocuments UCM095308 pdf Device Labehng Guidance G91 1 March 8 1991 http www fda gov MedicalDevices Dey Blue book memo iceRegulationandGuidance GuidanceDoc uments ucm081368 htm General Program Memorandum GO038 01 MDUFMA http www fda gov downloads Medical Devices DeviceRegulationandGuidance O vervie
5. 1 1 instructions for use I IIa 25 13 3
6. 6 Device Labeling Guidance G91 1 i i i ak
7. 21 CFR PART801 62 2 OO
8. 1 1 _ iDevie Labeing Guidance WD 0 EG ESSENTIAL REQUIREMENTS RN a Content of the Instractions for Use r ET ESSENTIAL REQUIREMENTS
9. GENERAL DEVICE LABELING REQUIREMENTS STERILE DEVICE LABERING GMP Device Labeling Guidance G91 1 COUNCIL DIRECTIVE 93 42 EEC Label and Instruction for Use for Medical Devices September 90 385 EEC 98 79 EEC 16th 2011 j i ji
10. 21 CFR PART801 109 Warning 21 CFR PART801 109 Precautions 21 CFR PART801 109 Special Patient Populations Device Labeling Guidance Adverse
11. O suk ru 3 6 Ri 5 21 CFR PART801 5
12. j i i ji ji FDA i ji i Devi
13. 21 CFR PART801 4 21 CFR PART801 5 801 109 1 1 1
14. FD amp D Act Section 352 3 21 CFR PART801 109
15. ij FDA i i iDevice Labeling Guidance I 1 ANNEX I ESSENT
16. 1 ICER EART9015 1
17. i i Device Labeling Guidance IV ANNEX I ESSENTIAL REQUIREMENTS 13 3j Content of the Instractions for Use Content of the Instractions for Use r 17 3 10 0310004 SE
18. i a i FDA i i b IM i i 2 ji i Device Labeling Guidance or Use g 17 3 10 0310003
19. 4 3 Ml a PMS PMS A
20. 9 10 11 92 2 Federal Food Drug and Cosmetic Act FD amp C Subchapter IL Sec 321 lt abel m labeling Label Labeling Label 1 Indications For Use 21 CFR PART801 5 801 109 I Qc gt Contraindications
21. i Device Labeling Guidance V ANNEX I ESSENTIAL REQUIREMENTS 13 3 k Content of the Labelk Content of the Instractions for Use 1
22. 1 21 CFR PART801 5 801 109 1 21 CFR PART801 109 uu OO
23. Content of the Label b 21 CFR 801 5 ontent of the Instractions for Use c lt I NE I ANNEX I ESSENTIAL REQUIREMENTS 13 6
24. Content of the Label k Content of the Instractions for Use 7 1 4
25. i i 1 i 2 i 3 i 1 i 2 1 H i 4
26. 4 8 1 9 0 0 OP 1 3 5 gt 2 a i 7 1 1 131 0 8 MM EN
27. il 1 63 2 63 2 14 15 16 17 18 19 2001 12 14
28. 3 2 1 iP i HMS 2 Sa 3
29. 21 CFR PART801 5 1 ES
30. I Content of the Instractions for Use k ANNEX I ESSENTIAL REQUIREMENTS 3 6 h Content of the Instractions for Use o NM 17 3 10 0310003 21CFR_Parts 801 ao OTC 1 OTC
31. ANNEX I ESSENTIAL REQUIREMENTS 13 5 Oontent of the Instractions for Use p ANNEX I ESSENTIAL REQUIREMENTS 13 6 c i i
32. 2012 12 IMDRF Medical TInternational Device Regulators Forum Label Instructions for Use 2011 9 16
33. 9 100 26 396 E 15 29
34. Content of the Label b ANNEX I ESSENTIAL REQUIREMENTS 13 4 i 1 2 Content of the Label k i 3 i I ANNEX I ESSENTIAL REQUIREMENTS 13 6 Content of the Instractions for Use d b i i
35. 21 CFR PART801 109 Device Labeling Guidance G91 1 EU COUNCIL DIRECTIVE 93 42 EEC 90 385 EEC 98 79 EEC GHTF Label and Instruction for Use for Medical Devices September 16th 20 11 ji i Device Labeling Guidance I ANNEX 1 ESSENTIAL REQUIREMENTS 13 6 q Content of the Instractions for Use T u ANNEX I ESSENTIAL REQUIREMENTS 13 3 b ANNEX I ESSENTIAL REQUIREMENTS 13 3 n ANNEX I ESSENTIAL REQ
36. 0310004 1 2 3 4 5 00 7 8 9 10 11 12 13 1 2 3 4 5 1 6 1 7 8
37. Labeling Regulatory Requnrements for Medical Devices 2 Labeling 21 CFR PART801 Device Labeling Guidance Name and Place of Business 21 CER PART801 1 Intended Use 21 CFR PART801 4 Adequate Direction
38. REQUIREMENTS 13 6 6 i 1 2 i 3 i Content of the Instractions for Use r 1 i i
39. 17 3 10 0310003 21C F R Parts 801 Labeling 21 CFR PART801 109 16 298 JMDN
40. GHTF Labeling 3 EU Label E GHTF Label A 63 2
41. p 9 ae i Device Labeling Guidance WI 3 Pe Content of the Instractions for Use t 0 REQUIREMENTS Content of the Instractions for Use q 13 6 n 17 3 10 0310003
42. i section 518 i FDA section 518 iFDA i 1 i i 3 ji i i Device Labeling Guidance I Ko Content of the Instractions for Use e
43. 1 ANNEX I ESSENTIAL ji REQUIREMENTS 13 3 ANNEX I ESSENTIAL
44. CO AnEoUinEENrs 3 6 e Content of the Instractions for Use 0 NRRSMAROEMR Device Labe ing Guidance VI Pk Content o the Instractions for Use m Ss ANNEX I ESSENTIAL REQUIREMENTS 2 STT Ne EAN
45. 68 9 3 4 1
46. 1 HH i ANNEX 1 ESSENTIAL REQUIREMENTS Content of the Instractions for Use p 13 3j Bo Content of the Instractions Content of the Instractions for Use i 1 i i
47. 2002 2005 3 10 0310003 0310001 A4 4 8
48. 1 O 1 21 CFR PART801 5 COUNCIL DIRECTIVE 93 42 EEC Label and Instruction for Use for Medical Devices September 90 385 EEC 98 79 EEC 16th 2011 Device Labeling Guidance G91 1 AI ESSENTALREUIREMENTS
49. i Device Labeling Guidance VI i ji i i ji i
50. i j lt i ji i j i Device Labeling Guidance IV ANNEX I ESSENTIAL REQUIREMENTS 13 3 j
51. Content of the Label k ANNEX I ESSENTIAL REQUIREMENTS 3 1 1 1 i 3 6b Content of the Label 5 _ Gontent of the Labelj
52. 25 G H 1 GHTF Device Labeling Guidance G91 1 O OTC EU GHTF COUNCIL DIRECTIVE 93 42 EEC Label and Instruction for Use for 90 385 EEC 98 79 EEC Medical Devices September 16th 2011
53. 2 3 4 5 6 7
54. 21 CFR PART801 5 801 109 COUNCIL DIRECTIVE 93 42 EEC Label and Instruction for Use for Medical Devices September Device Labeling Guidance G91 1 90 385 EEC 98 79 EEC 16th 2011 1 i i j OTC 21 CFR Part 801 i 21 CFR 809 10 i Device Labeling Guidance 1 i 21 CFR 801 109
55. i i i i 1 i 2 3 1 i 3 i
56. 21CFR_Parts 801 ao 1 1 21 CFR PART801 109 1 1 21 CFR PART801 109 68 7 1
57. 3 Content of the Instractions for Use r i
58. __ i i i Ii Device Labeling Guidance W EU COUNCIL DIRECTIVE 93 42 EEC 90 385 EEC 98 79 EEC Label and Instruction for Use for Medical Devices September 16th 2011 i i i
59. 2 3 NS 4 1 CFR PART801 109 1 2 2 1 bs
60. i 1 i i 3 i ANNEX I ESSENTIAL i 4 REQUIREMENTS 13 3j i 1 i Content of the Instractions for Use q
61. ANNEX 1 ESSENTIAL REQUIREMENTS BaD Content of the Label i Content of the Instractions for Use am ontent of the Label h MET HE 1 Content of the Label g 13 6 d 1 Content of the Label g
62. ANNEX I ESSENTIAL j REQUIREMENTS 13 6 e i i i i ANNEX I ESSENTIAL REQUIREMENTS 13 6 k
63. 21 CFR PART801 5 16 7 20 0720022 O 1 Device Labeling Guidance G91 1 COUNCIL DIRECTIVE 93 42 EEC Label and Instruction for Use for Medical Devices September 90 385 EEC 98 79 EEC 16th 2011 PPP
64. i i i ji i FDA i i Ii Device Labeling Guidance 17 3 10 0310003 21CFR_Parts 801 ao O
65. REQUIREMENTS 13 6d TP REQUIREMENTS 13 6 m 4 Content of the Instractions for User 17 3 10 0310004 21CFR_
66. 3 FD amp D Act Section 352
67. Content of the Label d 2 GHTF ES EU GHTF COUNCIL DIRECTIVE 93 42 EEC abeliandiInstruction TonUse for JNN ri eRe 90 385 EEC 98 79 EEC Medical Devices September 16th 2011 O O a Oo Oo 17 3 10 0310004 21C F R Parts 801 1
68. i i i Device Labeling Guidance X EU COUNCIL DIRECTIVE 93 42 EEC 90 385 EEC 98 79 EEC ANNEX I ESSENTIAL REQUIREMENTS 13 6 b Label and Instruction for Use for Medical Devices September 16th 2011 Content of the Label k Content of t
69. 21 CFR PART801 1 Device Labeling Guidance G91 1 COUNCIL DIRECTIVE 93 42 EEC 90 385 EEC 98 79 EEC Label and Instruction for Use for Medical Devices September 16th 2011 ANNEX I ESSENTIAL REQUIREMENTS 13 3 a Content of the Label c Content of the Instractions for Use b
70. 6 i108 i 4 5 4 1
71. 2 1 10 Device Labeling Guidance G91 1 EU COUNCIL DIRECTIVE 93 42 EEC 90 385 EEC 98 79 EEC Label and Instruction for Use for Medical Devices September 16th 2011 ANNEX I ESSENTIAL REQUIREMENTS 13 6 n Content of the Instractions for Usej
72. ANNEX I ESSENTIAL REQUIREMENTS Content of the Labelj 13 3m Content of the Labelj Content of the Istractions for Use k ANNEX 1 ESSENTIAL REQUIREMENTS Content of the Instractions for Use k 3 6 d Content of the Instractions for Use k
73. 13 6 COMMISSION REGULATION EU No 207 2012 of IMarch 2012 on electronic instructions for use of medical devices Directive 90 385 EEC 93 42 EEC Web X PET MRI CT 4 GHTF GHTF Global Harmonization Task Force 1992
74. PT 1 a er 1 0 EE ji Content of the Instractions for Use s
75. 1abeling Labelhing 21 CFR PART801 Device Labeling Guidance EU GHTF Label
76. Content of the Instractions for Use s
77. 4 5 EU COUNCIL DIRECTIVE 93 42 EEC 90 385 EEC 98 79 EEC Device Labeling Guidance G91 1 Label and Instruction for Use for Medical Devices September 16th 2011 Content of the Label k
78. 3 4 lt 21 CFR PART801 109 Device Labeling Guidance G91 1 EU COUNCIL DIRECTIVE 93 42 EEC 90 385 EEC 98 79 EEC GHTF Label and Instruction for Use for Medical Devices September 16th 2011
79. Content of the Instractions for Use T Content of the Instractions for Use 17 3 10 0310003 21CFR_Parts 801 ao 3 5 1 0 Se
80. a 1 1 6 1 2 3 4 LR 6 2
81. IAL REQUIREMENTS 13 6 Content of the Instractions for User te Content of the Instractions for Use p 1
82. Parts 801 Gy 1 3
83. Reactions 21 CFR PART801 109 rau 7IT 1 Prescription Device 21 CFR PART801 109 Labeling 21 CFR PART801 109 TFD amp C 502 Labeling mm 3 EU COUNCIL DIRECTIVE 93 42 EEC Annex 1 183 1 13 1
84. UIREMENTS 13 3 b Content of the Label b Content of the Label a Content of the Instractions for Use a i i i Device Labeling Guidance V ANNEX I ESSENTIAL REQUIREMENTS 13 3 k
85. ce Labeling Guidance Content of the Instractions for Use p 17 3 10 0310004 21CFR_Parts 801 NO 1 2 1
86. e Instractions for User Ei 17 3 10 0310004 SE a 1 2 2 1 2
87. he Instractions for Use q Content of th
88. w MedicalDeviceUserFeeandModer nizationActMDUFEMA ucm109203 pdf EU COUNCIL DIRECTIVE 93 42 EEC of 14 June 1993 concerning medical devices http eur lex europa eu LexUriServ Le xUriServdo 7uri CONSLEG 1998L0042 2 0071011 en PDE COMMISSION REGULATITON EU No 207 2012 of March 2012 on electronic instructions for use of medical devices http eur lex europa eu LexUriServ Le xUriServ do uri OJ L 2012 072 0028 003 1 RN PDE GHTT Label and Instructions for Use for Medical Devices GHTF SG1 N70 2011 September 16th 2011 http www imdrf org documents doc gh tf sg1 asp C 1 EU GHTF GT 1 63 63
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