| 我国医疗器械GMP实施的法律思考 |
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| 引用本文： | 蒋海洪.我国医疗器械GMP实施的法律思考[J].中国医疗器械信息,2010,16(12):42-44,65. |
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| 作者姓名： | 蒋海洪 |
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| 作者单位： | 上海医疗器械高等专科学校,上海200093 |
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| 基金项目： | 上海医疗器械高等专科学校科研启动基金资助项目 |
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| 摘 要： | 我国拟于明年1月起实施《医疗器械生产质量管理规范》,这是有监管法规以来医疗器械监管法律体系的明显进步,将对医疗器械行业产生巨大影响。文章从我国医疗器械GMP实施的法律定性、法律依据、法律意义等方面,对医疗器械GMP实施从法律的角度进行了全景思考。
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| 关 键 词： | 医疗器械 GMP 监管法规 |
Legal Consideration of the Implementation of GMP for Medical Device |
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| JIANG Hai-hong.Legal Consideration of the Implementation of GMP for Medical Device[J].China Medical Devices Information,2010,16(12):42-44,65. |
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| Authors: | JIANG Hai-hong |
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| Affiliation: | JIANG Hai-hong Shanghai Medical Instrumentation College(Shanghai 200093) |
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| Abstract: | China will implement ＂Medical Device Good Manufacturing Practice＂ in January next year,which has been a remarkable progress on the legal system of medical device supervision since supervision laws come out,and will have a great impact on the medical device industry.Articles take a panoramic legal view on the implementation of GMP for medical devices,including the legal nature,legal basis,and legal sense etc. |
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| Keywords: | medical device GMP supervision law |
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