医疗卫生装备2026，Vol.47Issue(6)：82-86,5.DOI:10.19745/j.1003-8868.2026095
医疗器械技术审评与不良事件监测的协同机制及实证分析
Synergistic mechanism and empirical analysis of medical device technical review and adverse event surveillance
摘要
Abstract
The synergistic relationship between technical review of medical devices and adverse event monitoring was described during the risk control of the entire medical device lifecycle.A paradigm for adverse event analysis based on technical review and its application in the case study of a hemostatic clamp were introduced.It highlighted the need to conduct focused reviews of submission documents including risk management documentation,performance study data and product instructions for use by analyzing adverse event monitoring information during the technical review of medical devices.The reform directions were pointed out such as unified terminology,data standardization and feedback institutionalization,thereby providing guidance for improving the regulation of medical devices throughout their entire lifecycle.[Chinese Medical Equipment Journal,2026,47(6):82-86]关键词
医疗器械监管/技术审评/不良事件监测/协同机制/闭合夹Key words
medical device surveillance/technical review/adverse event monitoring/synergistic mechanism/hemostatic clamp分类
医药卫生引用本文复制引用
沈晓华,丘婧婷,张龙瑛,刘张嫔,李栋,赵燕..医疗器械技术审评与不良事件监测的协同机制及实证分析[J].医疗卫生装备,2026,47(6):82-86,5.基金项目
国家药品监督管理局药物警戒研究与评价重点实验室科技项目(2023100) （2023100）
福建省药品监督管理局科技项目(2023012) （2023012）
