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构建医疗器械警戒体系的路径探究

王丽 张培茗 夏兵 王新茹

医疗卫生装备2024,Vol.45Issue(6):83-86,4.
医疗卫生装备2024,Vol.45Issue(6):83-86,4.DOI:10.19745/j.1003-8868.2024117

构建医疗器械警戒体系的路径探究

Path to establish medical device vigilance system

王丽 1张培茗 2夏兵 1王新茹1

作者信息

  • 1. 河南省药品评价中心,郑州 450008
  • 2. 上海理工大学健康科学与工程学院,上海 200093
  • 折叠

摘要

Abstract

The current situation of the medical device vigilance system was described in China,and the guiding role of risk management as the guiding ideology for constructing the system was introduced.The path of constructing the system involved in clarifying the responsible body,developing the main contents and correlating the risk information.It's pointed out that the system had to be improved in terms of regulation,management and technology.[Chinese Medical Equipment Journal,2024,45(6):83-86]

关键词

医疗器械警戒体系/医疗器械不良事件/风险管理

Key words

medical device vigilance system/medical device adverse events/risk management

分类

医药卫生

引用本文复制引用

王丽,张培茗,夏兵,王新茹..构建医疗器械警戒体系的路径探究[J].医疗卫生装备,2024,45(6):83-86,4.

基金项目

河南省软科学研究计划项目(232400410219) (232400410219)

医疗卫生装备

OACSTPCD

1003-8868

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