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???????????????????????1?????MDSAP??????QSR820???

ʱ: 2018-05-08 17:47 Դ: :
3??Brazilian Health Surveillance Agency (ANVISA)???? 6??????????3??????????????? 3??ANVISA???? ????ù?FDA QSR820???????????????????CMDCAS????????????????????????????????????????????????????????????????????????

???? 3??Brazilian Health Surveillance Agency (ANVISA)????

6??????????3???????????????

3??ANVISA????

????ù?FDA QSR820???????????????????CMDCAS?????????????????????????????????????????????????????????????????????????????????ISO??鼰CE??飬???????aaa?????????Э?????????????????ù?FDAQSR820?????????9000????????????MDSAP??顣???????????????????t??

4??MDSAP?????????

4?????????忼???????????

???м?10??????????????????????????????????????????????????t???????2019??1??1??????????????????????????????????????????????CMDCAS?MDSAP?????????飬net???????1?????MDSAP??????QSR820?????IMDRF???????????????????????????????????????iso9001???????????

9??MDSAP??????????????????????????????????????????

4??Therapeutic Goods Administration of Australia (TGA)?????????

4??TGA?????????

1??European Commission???

6??Japan Pharmaceuticals and Medical Devices Agency (PMDA)???

1??US Food and Drug Administration (FDA)?ù?

?????/??? QQ??vhao??

FDA?????? MDSAP???濼???????????? FDA???й??????1?Σ???FDA????л????? MDSAP?鳭?????滻???ο????????for cause ???????Compliance Follow-up??????????????????????С?

??2017??1??1????2019??1??1????????????????????????IMDRF????????????????????????????????????

?????/??? QQ???????

3???????????????????

8??MDSAP?????????????????????????????

5??MHLW & PMDA???

6??ISO??????????????MDSAP??

1??USA FDA?ù?

2?????????????????????????????????????????IMDRF????GHTF??????????????????????????????ISO?汾??vhao????????????????????

7??China Food and Drug Administration?й?

8??Russian Ministry of Health?????

??????????????????????????????????????

2??Health Canada Medical Devices Bureau???????

????????1?????MDSAP???????????????1????????????QMS??????????????????????QMS???????????????????÷?????????????????????????IMDRF??????????????IMDRF????????????????????????????????????ù???????????????FDA??????????????????????????????????????TGA???????????????????PMDA?????????????????????ANVISA????????????????????????

??????????????ISO??μ?MDSAP?????????????????????QMS??????????????????t??

1??????????1?????MDSAP????????????????? ?????/??? QQ????????????????塣??????sgs?????????

1??US Food and Drug Administration (FDA)?ù?

2??The World Health Organization (WHO)????????????

5??Japan??s Ministry of Health, Labour and Welfare, and the JapanesePharmaceuticals and Medical Devices Agency???

????????????16????????????????????????????QMS????????????????????????κα????????????net??

??????????CFDA,FDA,CE????

?????????????1?Σ????????2016?????????mdsap?????????????TGA?????п???????????????????ISO??2003?????????????????????????????????????????????,TGA??????MDSAP???????????????????????????????????

????????????????????????????????????????????????????????к??????????????MDSAP??????????????J-QMS?????

???????л?????ISO????????????????????????????????????????κ??????????????????????????????

4??Australia Therapeutic Goods Administration (TGA)?????????

5?????????????????MDSAP???????????

??????????????????????????????????????MDSAP??QMS?????????????????????????????????????????

MDSAP?????????????2014??1??1???????qsr820?????????MDSAP???濼?????????????????????Щ??????????????Ч?????Ч??????????????????????????????Ψ???????????????FDA????????????????????????????????

?й???????????ù??蹩????FDA????, ???????1?Ρ?????vhao???й??е??ù??е????????з? 10%,?????й?????????FDA??ù??????????????????????13%, ????FDA???й??????????????; FDA???й??????????????????50% ?????????,??FDA?????????"?????"?????????Ψ1 18% ~ 28% ,?????????????????? 47%?????

3??Brazilian Health Surveillance Agency (ANVISA)????

5??European Commission Directorate General Health andConsumers???

2???1?????????

TGA???????????????????????????????????????????????????????????????Ч?????Ч???????1??qsr??????????????Ψ???????????????FDA????????????????????????????????

7?????MDSAP??????????????????????????

1???????????????

????ù??????????????о??????????????й?????????????????????MDSAP???濼???????ANVISA??е???????????????????????????????????????????????? ???????????????ANVISA????????MDSAP???濼???????ANVISA??????鳭?????????????????????顣????????

????????ISO/YYT 0287, ISO/YYT 0316, QSR820, JGMP, GMP????????

ANVISA??????????????????е?III??????IV????????GMP?????????net???????1?????MDSAP??????QSR820????????????????????????顣???aaa?????????

2??Health Canada Medical Devices Bureau???????

3??MDSAP??????????????

??????????????????????????????????м??飬MDSAP???????????????????????????????????????????????????????н?????????????????????????????????????????????MDSAP??????????????????????????????????????????????????????????á?????5?????????????MDSAP?????????????1????????????????? 2??Canada???????

5??????????????????

7???????????????????????????????

????????1??????" [ Medical Device Single Audit Program(MDSAP)]?????ù?(FDA)???????????(TGA)??????(ANVISA)?????????(HC)?????(MHLW)5?????????????????μ??1?????????????÷??????????1???1??????????

 
 
 

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