中美医疗器械生产企业监督管理之比较与借鉴  

The Comparison and References of the Medical Device Manufacturers’ Supervision and Management Between the USA and China

作　　者：徐君[1] 邵蓉[1] 

机构地区：[1]中国药科大学,南京210009

出　　处：《中国医疗器械信息》2007年第7期43-45,共3页China Medical Device Information

摘　　要：比较中美两国对医疗器械生产企业监督管理的一般规定、生产的质量体系检查、生产企业的市场准入要求和上市后的监测等方面的差异。The differences between the USA and China in the general policy conditions, the inspections of the production quality system, market access requirements, post-marketing surveillances and so on of the the medical device manufacturers＇ supervision and management have been compared in this paper.

关 键 词：医疗器械 监督管理 生产企业 

分 类 号：F203[经济管理—国民经济]