医疗器械安全与性能基本要求与中国的医疗器械监督管理

Basic Requirements of Safety and Performance of Medical Devices and Administration of Chinese Medical Device

目的正确理解"医疗器械安全与性能基本要求",为加强我国的医疗器械监管提供参考。方法着重分析了"医疗器械安全与性能基本要求"针对的客体;全寿命周期的概念;预设用途的概念。结果与结论制订医疗器械安全与性能基本要求,填补我国医疗器械监管法规空白,理顺法规与技术标准的关系,强化企业责任,简化行政手续,使符合安全与性能基本要求的医疗器械能及时用于医疗服务,最大限度地保护公众利益,是我国医疗器械监管法规制修订中的重要课题。

Objective Understanding correctly The Basic Requirements of Safety and Performance of Medical Devices,was a reference for strengthening administration of Chinese medical devices.Methods To analyze the object of The Basic Requirements of Safety and Performance of Medical Devices,concept of full life-cycle and intended use.Results and Conclusion It is the important issue of the regulation amendment of medical devices that drawing the basic requirements of safety and performance of medical device,filling gaps in regulatory rules of Chinese medical devices,rationalizing the relationship between regulations and technical standards,strengthening corporate responsibility and simplifying administrative procedures so that the medical devices met basic requirements of safety and performance are used in time in medical services,to maximize the protection of the public interest.