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 Classification and Regulation of Medical Devices in China

作　　者：郭世富[1] 黄颖[1] 母瑞红[1] 李静莉[1] 

机构地区：[1]国家食品药品监督管理总局医疗器械标准管理中心,中国食品药品检定研究院,北京市100050

出　　处：《中国医疗器械杂志》2016年第5期355-358,共4页Chinese Journal of Medical Instrumentation

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。This paper introduces the domestic device regulatory classifi cation. Risk factors of medical equipment are analyzed. Combined with the analysis of the present situation of medical device regulatory classifi cation in china, this paper puts forward advice to reform and improve China＆#39;s medical device regulatory classifi cation system.

关 键 词：医疗器械 分类监管 改革 

分 类 号：F203[经济管理—国民经济]