中国药物评价2025，Vol.42Issue(2)：81-85,5.
警戒维度下基层监测机构对医疗器械上市后风险管理的实践与思考
Practices and Reflections of Post-market Risk Management of Medical Devices by Primary Monitoring Organizations under the Vigilance Dimension
摘要
Abstract
This study focuses on the field of adverse event monitoring of medical devices.By analyzing the risk management processes and models of medical devices after they are launched on the market,it examines the existing problems in the current adverse event moni-toring system of medical devices.From the perspective of the work of grassroots monitoring institutions,it proposes measures such as strengthening cross-departmental collaboration,promoting standardization and intelligent construction,improving monitoring technical means,optimizing the paths and mechanisms for risk reporting,strengthening the main responsibility of the registrants in monitoring,and enriching monitoring tools.It explores several key focal points for constructing the medical device vigilance system,with the aim of provi-ding useful ideas and references for the in-depth implementation of medical device vigilance work.关键词
医疗器械不良事件/医疗器械警戒/风险管理/模式分析/提升监测措施Key words
Medical device adverse events/Medical device vigilance/Risk management/Pattern analysis/Enhance monitoring measures分类
预防医学引用本文复制引用
王振东,玄怡,袁明辉,牛惠芳,杨建卫,曹建军,王茜,赵玉娟..警戒维度下基层监测机构对医疗器械上市后风险管理的实践与思考[J].中国药物评价,2025,42(2):81-85,5.基金项目
中国药品监督管理研究会立项课题(项目编号:2024-Y-Q-010 （）
项目名称:医疗机构医疗器械不良事件风险信号报告规范研究) （）
