Wu Jing, Jin Le
Center for Medical device Evaluation, NMPA, Beijing, 100076.
Zhongguo Yi Liao Qi Xie Za Zhi. 2024 Jul 30;48(4):451-456. doi: 10.12455/j.issn.1671-7104.230593.
In order to achieve precise risk control of medical devices, it is necessary to establish a scientific evaluation system throughout the entire life cycle of medical devices that focuses on risk identification and risk control. This study summarizes the medical device adverse event monitoring system of the US on regulatory agencies and regulatory law, adverse events reporting forms and time limits, adverse event database, adverse event report analysis and evaluation, as well as adverse event feedback and control. Furthermore, some examples are provided to illustrate the application of the MAUDE database in risk analysis, physical and mechanical performance research, and clinical evaluation of medical device registration and application materials.
为实现对医疗器械的精准风险控制，有必要在医疗器械的整个生命周期内建立一个以风险识别和风险控制为重点的科学评估体系。本研究总结了美国医疗器械不良事件监测系统在监管机构与监管法律、不良事件报告表格及期限、不良事件数据库、不良事件报告分析与评估以及不良事件反馈与控制等方面的情况。此外，还提供了一些实例来说明MAUDE数据库在医疗器械注册及申请材料的风险分析、物理和机械性能研究以及临床评估中的应用。
