中国药物警戒 ›› 2011, Vol. 8 ›› Issue (12): 719-721.

• 医疗器械召回与风险管理对策研究 • 上一篇    下一篇

医疗器械召回实施策略研究

文强1, 董放2, 王刚2, 郭雪2, 赵燕2, 郑立佳2   

  1. 1 重庆市药品不良反应监测中心,重庆 400014;
    2 国家食品药品监督管理局药品评价中心,北京 100045
  • 收稿日期:2011-11-09 出版日期:2011-12-10 发布日期:2015-07-30
  • 作者简介:文强,男,硕士,医疗器械不良事件监测和评价。课题负责人：杜晓曦,女,国家药品不良反应监测中心副主任。
  • 基金资助:
    国家软科学研究计划“医疗器械召回与风险管理现状及对策研究”（2010GXQ5B288）

The Study on Implementation Strategies of Medical Device Recall

WEN Qiang1, DONG Fang2, WANG Gang2, GUO Xue2, ZHAO Yan2, ZHENG Li-jia2   

  1. 1 Center for ADR Monitoring of Chongqing, Chongqing 400014, China;
    2 Center for Drug Reevaluation, SFDA, Beijing 100045, China
  • Received:2011-11-09 Online:2011-12-10 Published:2015-07-30

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摘要： 对缺陷医疗器械实施召回是国际惯例,对保障公众用械安全起到了重要的作用。本文基于《医疗器械召回管理办法(试行)》,对医疗器械产品召回问题的界定、召回深度的确定、召回方式、召回信息发布和召回效果评估等五个方面进行了研究和探讨。

关键词: 医疗器械, 召回, 缺陷, 风险

Abstract: Nowadays, implementing the defective medical device recall is the international practice, which has played an important role in keeping the public safety. The study, based on the regulation of medical device recall in China, has analysed 5 aspects of the medical device recall. Srategies including Problem identification, Depth determination, Methods choice, Information release and Effect evaluation.

Key words: medical device, recall, defect, risk

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