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我国医疗器械生产监管现状分析
引用本文:张欣涛. 我国医疗器械生产监管现状分析[J]. 中国医疗器械杂志, 2014, 0(5): 361-363
作者姓名:张欣涛
作者单位:中国食品药品检定研究院,北京市100050
摘    要:该文从医疗器械监管队伍、信用体系建设及《医疗器械质量管理规范》实施情况等方面介绍了我国医疗器械生产企业监管情况,提出了监管难点并给出监管建议。

关 键 词:医疗器械  生产  监管

Analysis of the Current Situation of Production Supervision of Medical Devices in China
Zhang Xintao. Analysis of the Current Situation of Production Supervision of Medical Devices in China[J]. Chinese journal of medical instrumentation, 2014, 0(5): 361-363
Authors:Zhang Xintao
Affiliation:Zhang Xintao (National Institutes for Food and Drug Control, Beijing, 100050)
Abstract:The paper introduces supervision situation of enterprises of medical devices from the aspects of supervision team of medical devices, construction of credit system and implementation of regulation ofquality management of medical devices, and raises supervision difficulties and puts forwards corresponding proposals.
Keywords:medical devices   production   supervision
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