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OA
Synergistic mechanism and empirical analysis of medical device technical review and adverse event surveillance
阐述了医疗器械技术审评与不良事件监测在医疗器械全生命周期风险控制中的协同关系,介绍了基于技术审评的不良事件分析范式及其在闭合夹案例分析中的应用,指出了医疗器械技术审评中应通过分析不良事件监测信息对风险管理资料、性能研究资料、产品使用说明书等申报资料进行重点审核,提出了术语统一化、数据标准化和反馈制度化的改革方向,为完善医疗器械全生命周期监管提供了参考.
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]
沈晓华;丘婧婷;张龙瑛;刘张嫔;李栋;赵燕
福建省药品审评与监测评价中心,福州 350003福建省药品审评与监测评价中心,福州 350003福建省药品审评与监测评价中心,福州 350003福建省药品审评与监测评价中心,福州 350003国家药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室,北京 100076国家药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室,北京 100076
医药卫生
医疗器械监管技术审评不良事件监测协同机制闭合夹
medical device surveillancetechnical reviewadverse event monitoringsynergistic mechanismhemostatic clamp
《医疗卫生装备》 2026 (6)
82-86,5
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)福建省药品监督管理局科技项目(2023012)
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