我国医疗器械注册制度与美国510K注册的比较

Medical Device Registration System Comparison between China and USA

文章围绕着我国医疗器械产品注册为主线的监督管理制度设计中出现的一些问题,与美国FDA实行的医疗器械注册制度进行了比较。分析了在医疗器械注册中进行"实质性等同"审批的基础要素,提出了我国医疗器械注册的制度设计问题及亟待解决的一些基本要点。

The paper compares the medical device registration system between China and FDA in USA, with the main focus on the problems of design default of supervision and management in Chinese system, it analysis the primary elements of substantial equivalence approval in medical device registration, and points out the design defaults of our medical device registration system and the basic points which need to be handled out.