| 加强国际医疗器械召回信息监测,提高上市后医疗器械监管能力 |
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| 引用本文： | 陈亮,张素敏,张承绪,武志昂. 加强国际医疗器械召回信息监测,提高上市后医疗器械监管能力[J]. 中国药物警戒, 2007, 4(6): 332-334 |
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| 作者姓名： | 陈亮 张素敏 张承绪 武志昂 |
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| 作者单位： | 国家食品药品监督管理局药品评价中心,北京,100045 |
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| 摘 要： | 召回是医疗器械上市后监管的重要措施,能显著消除或减少缺陷医疗器械的风险和危害。我国医疗器械召回管理在法规制度、信息监测等方面与发达国家相比都存在很大差距,应借鉴国外医疗器械召回管理的有效经验。其中,加强对全球医疗器械召回信息的监测是重要途径之一。
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| 关 键 词： | 召回 医疗器械 监测 |
| 文章编号： | 1672-8629（2007）06-0332-03 |
| 收稿时间： | 2007-10-09 |
| 修稿时间： | 2007-10-09 |
Strengthening the Monitoring of the Medical Devices Recall Notices and to Improving the Supervision Ability of the Post-Marketing Medical Devices |
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| CHEN Liang,ZHANG Su-min,ZHANG Cheng-xu,WU Zhi-ang. Strengthening the Monitoring of the Medical Devices Recall Notices and to Improving the Supervision Ability of the Post-Marketing Medical Devices[J]. Chinese JOurnal of Pharmacovigilance, 2007, 4(6): 332-334 |
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| Authors: | CHEN Liang ZHANG Su-min ZHANG Cheng-xu WU Zhi-ang |
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| Abstract: | It is important to recall the post-marketing defected medical devices to reduce or eliminate the possible risks and damage.Compared to the developed countries,there is biger gap about the rec-all regulations,signal monitoring,et al.in China.We should learn the mature recall management from the foreign countries.It is significant to strengthen the monitoring of the global recall notices. |
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| Keywords: | recall medical devices monitoring |
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