| 医疗器械上市后安全性监测框架模式的构建实例研究 |
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| 引用本文： | 张素敏,张亮.医疗器械上市后安全性监测框架模式的构建实例研究[J].中国医疗器械杂志,2011,35(6). |
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| 作者姓名： | 张素敏 张亮 |
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| 作者单位： | 1. 华中科技大学同济医学院医药卫生管理学院武汉,430030;国家食品药品监督管理局药品评价中心北京,100045
2. 华中科技大学同济医学院医药卫生管理学院武汉,430030 |
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| 摘 要： | 针对心脏瓣膜典型案例,围绕信息收集、分析评价及控制环节存在的问题及可借鉴的经验进行访谈,剖析医疗器械上市后安全性监测过程中可能存在的问题,并提出改进建议.
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| 关 键 词： | 医疗器械 安全性 监测 案例分析 |
Research on the Lssues in the Process of Post-market Surveillance for Medical Devices Based on the Typical Case Analysis |
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| Zhang Sumin,Zhang Liang.Research on the Lssues in the Process of Post-market Surveillance for Medical Devices Based on the Typical Case Analysis[J].Chinese Journal of Medical Instrumentation,2011,35(6). |
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| Authors: | Zhang Sumin Zhang Liang |
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| Affiliation: | Zhang Sumin1,2,Zhang Liang1 1 The School of Medicine and Health Management,TongJi Medical College of HUST,Wuhan,430030,China 2 Center for Drug Reevaluation,SFDA,Beijing,100045,China |
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| Abstract: | Regarding the information collected,analysis and actions that have been taken,the issues in the process of the Postmarket Surveillance for Medical Device were analyzed,and some suggestions were given at the same time. |
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| Keywords: | medical device safety surveillance issues case analysis |
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