| 医疗器械不良事件监测-现状与展望 |
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| 引用本文： | 王兰明. 医疗器械不良事件监测-现状与展望[J]. 中国医疗器械杂志, 2004, 28(4): 282-289 |
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| 作者姓名： | 王兰明 |
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| 作者单位： | 国家食品药品监督管理局医疗器械司,北京,100810 |
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| 摘 要： | 介绍医疗器械不良事件的基本概念,论述美国、欧盟、日本和有关国际组织关于医疗器械不良事件监测的管理规定,并回顾和展望我国在该领域的相关工作.
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| 关 键 词： | 医疗器械 不良事件 监测 上市后监督 |
| 文章编号： | 1671-7104(2004)04-0282-08 |
| 修稿时间： | 2004-04-09 |
Medical Devices'''' Adverse Events'''' Monitoring--the Present and the Future |
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| WANG Lan-mingState Food and Drug Administration,Beijing. Medical Devices'''' Adverse Events'''' Monitoring--the Present and the Future[J]. Chinese journal of medical instrumentation, 2004, 28(4): 282-289 |
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| Authors: | WANG Lan-mingState Food Drug Administration Beijing |
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| Abstract: | Some concepts related to the medical devices adverse events monitoring, and the laws and administrative regulations in the US, EU, Japan and some international organizations are introduced in the paper. Some works and efforts we have done in the past and what should be done in the near future in China are also outlined. |
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| Keywords: | medical device adverse event supervision and testing post-marketing supervision. |
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