江苏省科技期刊可视化阅读平台

导航条

江苏科技信息 ›› 2015, Vol. 32 ›› Issue (26): 66-67.doi: 10.3969/j.issn.1004-7530.2015.26.020

• 论文 • 上一篇    下一篇

我国医疗器械监管和风险管理现状分析

何水英, 张建同, 徐益民   

  1. 同济大学经济与管理学院,上海 200092;上海微创医疗器械(集团)有限公司,上海 201318;同济大学经济与管理学院,上海,200092;上海微创医疗器械(集团)有限公司,上海,201318
  • 出版日期:2015-09-15 发布日期:2015-09-15

Analysis on the Current Situation of Medical Device Supervision and Risk Management in China

He Shuiying, Zhang Jiantong, Xu Yimin   

  • Online:2015-09-15 Published:2015-09-15

摘要： 医疗器械产品的使用安全关乎人的生命,我国越来越重视医疗器械的风险管理,并通过完善国家立法和设立专门的权力机构来对医疗器械实施监管.文章介绍了医疗器械风险管理的理论,我国现行的医疗器械立法和监管系统,分析了我国医疗器械风险管理的现状,总结了我国医疗器械监管和风险管理的关键问题,并提出了解决建议.

关键词: 医疗器械, 风险管理, 生命周期, 危害分析, 故障模式与效应分析

Abstract: The safety of medical devices is closely related to the health of patients ,much more attentions have been payed to the risk management of medical devices in China. In this paper, the theories of risk management ,the current Chinese legislation and supervision system which concered with medical devices were introduced. Moreover, the current situation and key problem of medical device risk management and supervision in China were summarized, and some suggetions to solve these issues were also proposed.