| 医疗器械产品召回制度探讨与典型案例分析 |
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| 引用本文： | 王刚,张素敏,曹立亚. 医疗器械产品召回制度探讨与典型案例分析[J]. 中国药物警戒, 2005, 2(4): 215-219 |
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| 作者姓名： | 王刚 张素敏 曹立亚 |
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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,北京,100061 |
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| 摘 要： | 着重介绍了国内外医疗器械产品召回制度现状,并以强生血糖仪、佳腾除颤器两起召回事件为案例,阐明整个召回事件处理的过程,旨在为我国建立和完善医疗器械产品召回制度提供借鉴。
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| 关 键 词： | 医疗器械 召回 血糖仪 除颤器 |
| 文章编号： | 1672-8629（2005）04-0215-05 |
| 收稿时间： | 2005-05-11 |
Medical Device Recall Discussion And Typical Cases Introduction |
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| WANG Gang,ZHANG Su-min,OAO Li-ya. Medical Device Recall Discussion And Typical Cases Introduction[J]. Chinese JOurnal of Pharmacovigilance, 2005, 2(4): 215-219 |
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| Authors: | WANG Gang ZHANG Su-min OAO Li-ya |
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| Abstract: | Something about medical device recall in- ternational and domestic were discussed in this artical. At the same time,two typical cases were introduced. Aims to provide some references to recall system estab- lishment in China. |
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| Keywords: | Medical device Recall Blood glucose meter Pacemaker |
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