| 我国医疗器械注册管理制度历史演变之分析 |
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| 引用本文： | 许伟.我国医疗器械注册管理制度历史演变之分析[J].中国医疗器械信息,2011,17(11):1-4,13. |
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| 作者姓名： | 许伟 |
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| 作者单位： | 国家食品药品监督管理局医疗器械技术审评中心,北京,100044 |
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| 摘 要： | 医疗器械注册管理是医疗器械监督管理工作的重要组成部分.我国的医疗器械注册管理制度从建立到发展,经历了15年时间.笔者通过回顾这短短十几年医疗器械注册管理制度的演变,总结了我国医疗器械注册工作的经验和目前存在的主要问题,为进一步完善医疗器械注册管理体系,提高医疗器械注册工作的质量和效率提供参考依据.
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| 关 键 词： | 医疗器械 注册管理 制度演变 |
Analysis on the Evolution of Administrative Rules for Medical Device Registration |
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| XU Wei.Analysis on the Evolution of Administrative Rules for Medical Device Registration[J].China Medical Devices Information,2011,17(11):1-4,13. |
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| Authors: | XU Wei |
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| Institution: | XU Wei Center for Medical Device Evaluation,State Food and Drug Adminstration(Beijing 100044) |
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| Abstract: | Registration on medical devices is one of the key parts of management and inspection system of medical device.The administration rules of medical devices have developed for 15 years since the establishment in 1996 in China.This paper has reviewed the evolution of administration rules on medical devices in the period.The accumulated experiences and the existed problems on medical device registration should supply evidences for further improvement of registration system as well as registration service with be... |
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| Keywords: | medical device registration management evolution of administration rules |
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