我国医疗器械分类监管改革的现状及思考

Present Situation and Thinking on the Reform of the Classifi cation and Regulation of Medical Devices in China

摘要: 该文介绍了我国医疗器械分类监管的情况，对影响医疗器械的风险因素进行分析，结合我国医疗器械分类监管的现状分析，提出改革和完善我国医疗器械分类监管体制的建议。

Abstract: This paper introduces the domestic device regulatory classification. Risk factors of medical equipment are analyzed. Combined with the analysis of the present situation of medical device regulatory classification in china, this paper puts forward advice to reform and improve China's medical device regulatory classification system.