| 医疗器械与药品受理注册检验管理程序比较 |
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| 引用本文： | 王敬,杨晓芳,成双红,王春仁. 医疗器械与药品受理注册检验管理程序比较[J]. 中国药事, 2011, 0(9): 851-852 |
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| 作者姓名： | 王敬 杨晓芳 成双红 王春仁 |
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| 作者单位： | (中国食品药品检定研究院,北京100050) |
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| 摘 要： | 目的为完善医疗器械管理体系提供参考。方法对医疗器械和药品在注册检验管理方面进行了比较,特别是在分类管理、注册检验内容和注册标准等方面。结果与结论医疗器械和药品在注册检验管理方面存在很大的差异,药品的管理体系相对成熟,能够为发展中的医疗器械管理体系提供借鉴。
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| 关 键 词： | 医疗器械 药品 检验 法规 |
Comparation of Medical Devices and Drugs Registration Test Management Procedure |
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| Wang Jing,Yang Xiaofang,Cheng Shuanghong,Wang Chunren. Comparation of Medical Devices and Drugs Registration Test Management Procedure[J]. Chinese Pharmaceutical Affairs, 2011, 0(9): 851-852 |
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| Authors: | Wang Jing Yang Xiaofang Cheng Shuanghong Wang Chunren |
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| Affiliation: | Wang Jing,Yang Xiaofang,Cheng Shuanghong and Wang Chunren(National Institutes for Food and Drug Control,Beijing 100050) |
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| Abstract: | Objective This will provide a reference for the perfection of medical devices regulation system.Methods This paper compared the regulation aspects of the medical devices and drugs in the registration management.There were some difference in classification management,registration test contentst and registration standards between medical devices and drugs.Results and Conclusion There were great difference in management system between medical devices and drugs.The drug management system is more mature and prov... |
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| Keywords: | medical device drug test regulation |
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