对医疗器械生产质量管理规范试点工作的思考  

Consideration on the Pilot Implementation of the Good Manufacturing Practice for Medical Devices

作　　者：郭准[1] 

机构地区：[1]国家食品药品监督管理局药品认证管理中心,北京100061

出　　处：《中国药事》2010年第5期464-466,共3页Chinese Pharmaceutical Affairs

摘　　要：目的在试点基础上总结经验,推进我国全面实施《医疗器械生产质量管理规范》。方法在对《医疗器械生产质量管理规范》试点情况和结果详细分析的基础上,讨论了试点成效和对今后的启示。结果与结论通过试点,为法规的完善和今后我国全面实施《医疗器械生产质量管理规范》奠定了基础,使其更加符合我国监管实际,切实将医疗器械质量体系管理提升到新水平。Objective To summarize the experience based on the pilot,and promote the all-round implementation of Good Manufacturing Practice for Medical Devices in our country. Methods Based on the pilot of Good Manufacturing Practice for Medical Devices and detailed analysis of the result,the effectand inspiration of the pilot have been discussed. Results and Conclusion The Pilot has laid a foundation for perfection of the regulations and all-round implementation of Good Manufacturing Practice for Medical Devices in our country in the future,making it further comply with supervision practice of our country and practically raising the quality management system of medical devices to a new level.

关 键 词：医疗器械生产质量管理规范 试点 质量体 

分 类 号：R955[医药卫生—药学] R197.39