“医疗器械安全有效基本要求”研究及其在我国的应用

The Application of Essential Principles of Safety and Performance for the Medical Devices

目的:研究IMDRF医疗器械安全有效基本要求的应用,为我国医疗器械上市前审查工作提供参考。方法:对IMDRF医疗器械安全与性能基本要求进行文献研究,并对基本要求清单的填报进行调查研究。结果与结论:医疗器械安全有效基本要求清单是实施基本要求的一种公认的方法。结合我国实际情况,应通过清单的设置将要求、方法、证据系统组织在一起,形成符合我国医疗器械市场准入路径的注册申报资料。

Objective： This article aim to study the IMDRF essential principles of safety and performance checklist, thus improve the medical devices premarket evaluation in China. Methods： Based on literature study and investigation study, an analysis is carried out on EP Checklist. Conclusions： EP checklist is a recognized method for implement the essential principles of safety and performance for the medical devices. Based on situation of China, we should build the medical devices premarket evaluation application documentation with EP checklist, thus unite the principles, method used to demonstrate conformity, and reference to evidence in a system way.