医疗器械GMP初探

A Preliminary Discussion on GMP for Medical Devices

医疗器械和药品的生产各有其特殊性。药品生产企业目前执行"药品生产质量管理规范"(GMP),用于医疗器械生产企业的GMP尚未问世。通过对比分析药品GMP和国际通用质量管理体系标准ISO9001,指出不能将基于ISO9001的ISO13485简单转为医疗器械的GMP;并对如何制定我国的医疗器械GMP提出一些设想,对确定医疗器械GMP的法律地位等方面也提出一些看法。

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.