| 我国医疗器械监管法规体系建设之思考 |
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| 引用本文： | 安抚东. 我国医疗器械监管法规体系建设之思考[J]. 中国药事, 2007, 21(7): 453-459 |
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| 作者姓名： | 安抚东 |
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| 作者单位： | 国家食品药品监督管理局,北京,100810 |
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| 摘 要： | 通过对美国、欧盟医疗器械法规体系分析研究，总结其管理经验及技术规范要求，给我国医疗器械监管体系改革，提出一些意见建议。
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| 关 键 词： | 医疗器械 监管 法规体系 改革 |
| 文章编号： | 1002-7777（2007）07-0453-07 |
Thinking on the Reform of Chinese Medical Device Regulatory System |
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| An Fudong. Thinking on the Reform of Chinese Medical Device Regulatory System[J]. Chinese Pharmaceutical Affairs, 2007, 21(7): 453-459 |
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| Authors: | An Fudong |
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| Affiliation: | State Food and Drug Administration, Beijing 100810 |
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| Abstract: | By systematic analysis on the medical device regulatory system in United States and European Union, this paper tries to summarize the management experience and related technical guidelines, so as to provide some comments and suggestions concerning the reform of medical device regulatory system in China. |
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| Keywords: | medical device regulation legal system reform |
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