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- W2377639942 abstract "As medical devices' manufacture and Pharmaceuticals' manufacture have their own specific characteristics, thepharmaceutical manufacturers, at present, are forced to carry out pharmaceutical GMP while medical devices' GMP has not yet been drawn up . This article .based on the analysis and the comparison between GMP regulation and ISO9001 Standard , intends to point out their differences and to explain why the medical device industry can not simply take ISO9001-based ISO 13485 as its GMP. Besides, this article presents some suggestions and tentative ideas in regard to working out Chinese Medical Device GMP and to establishing its legal status in China." @default.
- W2377639942 created "2016-06-24" @default.
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- W2377639942 date "2004-01-01" @default.
- W2377639942 modified "2023-09-25" @default.
- W2377639942 title "A Preliminary Discussion on GMP for Medical Devices" @default.
- W2377639942 hasPublicationYear "2004" @default.
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