医疗器械临床评价实践

Practice of Medical Device Clinical Evaluation

该文就医疗器械的临床评价活动,参考了国际、国内的医疗器械法规和指南文件,简要介绍了医疗器械临床评价的实施步骤、关注重点以及评价报告应包含的内容,以期为医疗器械注册申报、认证等相关人员提供临床评价方面的借鉴。

For medical device clinical evaluation activities,reference to international and domestic medical device regulations and guidance documents,this paper briefly introduces the implementation steps of clinical evaluation of medical devices,and focus on the evaluation report should be included in the content,provides reference for relevant personnel of medical devices registration and certification on medical device clinical evaluation practice.