| 医疗器械临床研究方式和监管的探讨 |
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| 引用本文： | 马建民,付金德. 医疗器械临床研究方式和监管的探讨[J]. 中国医疗器械信息, 2009, 15(2): 29-29,34 |
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| 作者姓名： | 马建民 付金德 |
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| 作者单位： | 江苏省食品药品监督管理局认证审评中心,南京,210002 |
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| 摘 要： | 本文叙述了我国医疗器械注册前临床试验或验证的方式以及监管存在的问题和解决方法的探讨。
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| 关 键 词： | 医疗器械 临床 |
Discussion of the Medical Device Clinical Research and Supervision |
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| MA Jian-min,FU Jin-de. Discussion of the Medical Device Clinical Research and Supervision[J]. China Medical Devices Information, 2009, 15(2): 29-29,34 |
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| Authors: | MA Jian-min FU Jin-de |
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| Affiliation: | ( Center for Certification ＆ Evaluation.jsfda (Nanjing 210002)) |
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| Abstract: | This paper describes the methods of medical devices clinical trials or validation in China, and analyses the problems in supervision of it to improve the methods. |
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| Keywords: | Medical Device Clinical |
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