IMDRF医疗器械单一检查项目介绍  

Introduction on Medical Device Single Audit Program of IMDRF

作　　者：徐玮 田少雷[1] 刘培英 董江萍[1] XU Wei;TIAN Shao-lei;LIU Pei-ying;DONG Jiang-ping(Center for Food and Drug Inspection of CFDA,Beijing 100061)

机构地区：[1]国家食品药品监督管理总局食品药品审核查验中心,北京100061

出　　处：《中国医疗器械信息》2018年第7期33-36,共4页China Medical Device Information

摘　　要：MDSAP是IMDRF的工作项目之一,旨在协调统一各监管机构的医疗器械检查程序和标准,最终实现国际检查结果的互认,以更好地发挥监管资源的作用。文章对MDSAP项目进行介绍,重点对IMDRF已发布的9个文件进行说明,为我国借鉴和转化其成果提供参考。MDSAP,being one of the IMDRF working programs,aims as to humanize the inspection procedures and standards of different regulatory authorities,finally to realize the mutual reorganization of audit results,consequently to better play the role of regulatory resources.MDSAP and 9 related documents issued by IMDRF are briefly introduced in this paper to provides reference for application and transformation of MDSAP.

关 键 词：医疗器械 IMDRF 单一检查项目 

分 类 号：R197.39[医药卫生—卫生事业管理]