欧盟医疗器械分类原则解析与启示

Analysis on Classification of Medical Devices in Europe

目的借鉴欧盟医疗器械分类原则,完善我国医疗器械分类规则。方法对欧盟医疗器械分类原则进行分析归纳,对比分析我国现有医疗分类目录和规则。结果与结论详细、具有可操作性的分类原则对我国医疗器械管理至关重要,需要在医疗分类规则中详细规定。

Objective To perfect our classification of medical devices based on the analysis of it in European. Methods To explain the meaning of classification of medical devices in Europe one by one and find differences between it in Europe and in China. Results and Conclusion We need to issue regulation about methods of classification of medical devices.