摘要
新修订的《医疗器械监督管理条例》及配套的注册管理办法等相关法规文件引入了很多GHTF医疗器械临床管理理念中新的概念和思路,本研究通过对GHTF医疗器械临床评价指导原则进行部分解读,利于理解我国现行的医疗器械临床技术审查指导原则。
Many new concepts and ideas of the New revision of the Regulations and related registration measures of medical device relevant laws and regulations such as file introduces are based on the study of GHTF medical instrument clinical evaluation guidelines.Interpretating the GHTF Medical Device Clinical Evaluation Guidance helps understanding the current medical device clinical technical review guidelines.
出处
《中国医疗器械信息》
2014年第12期10-13,65,共5页
China Medical Device Information
