介绍美国、欧盟等医疗器械 管理及法规的概况
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GHTF
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1938 The 1938 Food, Drug, and Cosmetic Act 1976 ( FDCA ) 1990( the Safe Medical Devices Act SMDA )
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(FDA)CDRH (Center for Devices and Radiological Health.) CDRH7ODE (Office of Device Evaluation)6
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25 55 20 (PMA)
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510(K)PMA510(K)(Pre- market Notification)(Substantially Equivalent) PMAPre-market Approva1
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90 (PMA)(45180
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1987(GMP) 1997GMPQuality System (QS) regulation QSR ISO 9OO1
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1I 23FDA
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520(g)Investigational Device Exemption IDE IDE(1)(2)(3)(4)(5)(6)()(7)(8) (9)(10)(11)
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1988 (AIMDCouncil Directive 90385EEC) (MDDCouncil Directive 9342EEC) (IVDDCouncil Directive 9879EEC) 1538
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1993CE1998613CE19941231CE1998CE20051222
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ab ()23a(1h)b(lh30d)ab64(30d)1318
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ab
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ISO 9000EN 46000EN 46000
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CE
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ab60 ()
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196619662OO22002 1989 TGA
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ab AIMD ()
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GMP
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GMP(ISO 9000)
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1998 HPFBI
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CMDCAS
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CAN/CSA ISO 13488-98 CAN/CSA ISO 13485-98
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ISO 13485/13488CMDCAS
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1 CMDCAS 2 QS 3
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1960200272005
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(GHTF)
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(Shonin)(Kyoka)
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19892700
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1993
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GHTF 1992(Global Harmonization Task Force [GHTF]
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GHTF4
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4ABCD
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ABCD
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5QSREN 46000ISO 9001ISO 13485
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5 930 282931 15 3233
34 78910 19202122 182627 111622 232426
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93/42/EEC 1993614 MDD
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23+12 98/79EEC19981027 2000/70/EC20001116 2001/104/EC20011272003929(EC) 1882/2003
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1
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2 3 4 5 6 7 8
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9 IX 18
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60 30 30 30
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60 30 30
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30
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188 b; a
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5Iabaaa
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10aCNSbb
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10 11 12 13 14 15 VIII 16
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10
10
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11
11 CE
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12 CE 13 14 15
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16
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17 CE CE18 CE19
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20 21 22 23
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I III
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II EC EC
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III EC EC IV EC
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V EC VI EC VII EC VIII
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IX X XI XII CE
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FDA
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21 CFR 21 Medical Devices ( Parts 800-1290 )
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800 801 803 806 807
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808 -- 809 -- 810 -- 812 -- 814 -- 820 --
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821 -- 860 861 862 864 866 -- 868
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870 -- 872 874 -- 876 -878 880 882
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884 886 888 890 892 895 898
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900 1000 -- 1002 -- 1003 -- 1004 1005 --
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1010 -- 1020 -- 1030 -- 1040 1050
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801
(a)(b)Company, Incorporated,The ,(e)
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a (b) (c) (d) (e) (f) (g)
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(a) (b) 40% (c)40%
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803
.
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(1)MDR MDR () (1) (2)
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(Caused or contributed ) (1) ; (2) ; (3) ; (4) ; (5) ; (6) .
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10FDA 803.33 FDA30
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130 2 5 5 1MDR2 MDRFDA5FDAFDA
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FDA3500A FDA
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810 --
FDA FDA (1) (2) (3)
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(1) (2)
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FDA30 FDA FDA FDA
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806
() FDA
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814 -- (PMA)
PMA III PMAPMA
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820 -- (CGMP)I
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- - - - - - - - - - -
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(DHR) DHR DMR (DMR)
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821 --
FDAFDAFDA519(e)(1),
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FDA3
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FDA10 (i) (ii) (iii) () (iv) (v) (vi) (vii)
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(1) (2) (3) (4) (5)
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860 1976528
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870--BCDEFDC-()
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870.1025 (a) (b) II()II870.1
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895
FDA()
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30
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1003--
a b c
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IECISO
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