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在用医疗仪器设备现状及监管对策思路
引用本文:马莉,杜堃,叶岳顺,吴夷,林联君,孙瑜,秦丽萍. 在用医疗仪器设备现状及监管对策思路[J]. 中国医疗器械杂志, 2014, 0(4): 295-298
作者姓名:马莉  杜堃  叶岳顺  吴夷  林联君  孙瑜  秦丽萍
作者单位:浙江省医疗器械检验院,杭州市310018
摘    要:该文通过获得的部分在用医疗仪器设备检测数据和相关信息,对在用医疗仪器设备现状进行了分析,从法规、标准、监管、生产制造和医疗机构等方面提出一些监管的构架和对策思路,以引起各方关注和共同探讨,为监管部门提供参考。

关 键 词:在用医疗仪器设备  现状分析  监管对策思路

Current Situations of Medical Devices in Use and Strategies on Supervising
Ma Li,Du Kun,Ye Yueshun,Wu Yi,Lin Lianjun,Sun Yu,Qin Liping. Current Situations of Medical Devices in Use and Strategies on Supervising[J]. Chinese journal of medical instrumentation, 2014, 0(4): 295-298
Authors:Ma Li  Du Kun  Ye Yueshun  Wu Yi  Lin Lianjun  Sun Yu  Qin Liping
Affiliation:(Zhejiang Institute for the Control of Medical Devices, Hangzhou, 310018)
Abstract:We are reporting in this article some analyzed data obtained from inspection and related information on current situations medical devices in use. Some ideas and suggestions are also proposed here on how to systematicaly and legaly inspecting and monitoring medical devices in use.
Keywords:medical devices in use  current situations evaluation and analyses  approaching on inspection strategies
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