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新旧医疗器械监督管理条例的差异性解析
引用本文:邵玉波,苑富强. 新旧医疗器械监督管理条例的差异性解析[J]. 中国医疗器械信息, 2014, 0(11): 1-4,9
作者姓名:邵玉波  苑富强
作者单位:中国食品药品检定研究院 北京 100050
摘    要:本文主要对新旧医疗器械监督管理条例进行理解分析,在此基础之上着重分析二者在医疗器械的定义、分类、注册管理和质量管理等方面的差异与联系,从而帮助读者进一步理解医疗器械监管工作的趋势和方向。

关 键 词:医疗器械  监督管理条例  风险管理  差异

Analysis of Differences BetweenNew and Old Medical Equipment Supervision and Management Regulations
SHAO Yu-bo , YUAN Fu-qiang. Analysis of Differences BetweenNew and Old Medical Equipment Supervision and Management Regulations[J]. China Medical Devices Information, 2014, 0(11): 1-4,9
Authors:SHAO Yu-bo    YUAN Fu-qiang
Affiliation:National Institutes for Food and Drug Control (Beijing 100050)
Abstract:This paper mainly analyzed and understood the new and old medical equipment supervision and management regulations, on the basis of the above, compared and analyzed the differences and relations on medical device classification, registration management and quality management and so on, in order to help the readers further understand the trend and direction of the supervision of medical devices, And talked about some of the understanding of the new regu at ons, only to supply reference.
Keywords:medical device  supervision and management regulations  risk management  difference
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