GHTF

1938 The 1938 Food, Drug, and Cosmetic Act 1976 ( FDCA ) 1990( the Safe Medical Devices Act SMDA )

(FDA)CDRH (Center for Devices and Radiological Health.) CDRH7ODE (Office of Device Evaluation)6

25 55 20 (PMA)

510(K)PMA510(K)(Pre- market Notification)(Substantially Equivalent) PMAPre-market Approva1

90 (PMA)(45180

1987(GMP) 1997GMPQuality System (QS) regulation QSR ISO 9OO1

1I 23FDA

520(g)Investigational Device Exemption IDE IDE(1)(2)(3)(4)(5)(6)()(7)(8) (9)(10)(11)

1988 (AIMDCouncil Directive 90385EEC) (MDDCouncil Directive 9342EEC) (IVDDCouncil Directive 9879EEC) 1538

1993CE1998613CE19941231CE1998CE20051222

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ISO 9000EN 46000EN 46000

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196619662OO22002 1989 TGA

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1998 HPFBI

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CAN/CSA ISO 13488-98 CAN/CSA ISO 13485-98

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1 CMDCAS 2 QS 3

1960200272005

(GHTF)

(Shonin)(Kyoka)

19892700

1993

GHTF 1992(Global Harmonization Task Force [GHTF]

GHTF4

4ABCD

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5QSREN 46000ISO 9001ISO 13485

5 930 282931 15 3233

34 78910 19202122 182627 111622 232426

93/42/EEC 1993614 MDD

23+12 98/79EEC19981027 2000/70/EC20001116 2001/104/EC20011272003929(EC) 1882/2003

1

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III EC EC IV EC

V EC VI EC VII EC VIII

IX X XI XII CE

FDA

21 CFR 21 Medical Devices ( Parts 800-1290 )

800 801 803 806 807

808 -- 809 -- 810 -- 812 -- 814 -- 820 --

821 -- 860 861 862 864 866 -- 868

870 -- 872 874 -- 876 -878 880 882

884 886 888 890 892 895 898

900 1000 -- 1002 -- 1003 -- 1004 1005 --

1010 -- 1020 -- 1030 -- 1040 1050

801

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