摘要
医疗器械临床评价是评价医疗器械安全有效性的重要方法和手段。结合有源医疗器械的特点,对有源医疗器械临床评价资料的常见问题进行探讨,以期指导注册申请人更好地完成有源医疗器械临床评价工作。
Clinical evaluation of medical devices is an important method and means to evaluate the safety and effectiveness of medical devices.Combined with the characteristics of active medical devices,this paper discusses the common problems of the clinical evaluation data of active medical devices,in order to guide the applicants to better complete the clinical evaluation of active medical devices.
作者
刘露
LIU Lu(Center for Medical Devices Evaluation,National Medical Products Administration,Beijing 100081)
出处
《中国医疗器械信息》
2020年第17期3-5,共3页
China Medical Device Information
关键词
有源医疗器械
临床评价
常见问题
active medical devices
clinical evaluation
common problems
