新版《医疗器械临床试验质量管理规范》要点解读与思考  

Interpretation and Discussion on the Key Points of the New Edition of Standard for Quality Management of Medical Device Clinical Trials

作　　者：潘辛梅 谢林利 马攀 谢江川 曹丽亚 陈勇川 PAN Xinmei;XIE Linli;MA Pan;XIE Jiangchuan;CAO Liya;CHEN Yongchuan(Department of Pharmacy,The First Affiliated Hospital of Army Medical University(Third Military Medical University),Chongqing 400038,China)

机构地区：[1]陆军军医大学(第三军医大学)第一附属医院药学部,重庆400038

出　　处：《中国医疗设备》2023年第4期119-123,135,共6页China Medical Devices

基　　金：重庆市软科学研究计划(cstc2018jsyj-zdcxX0079)。

摘　　要：本文通过比较新版和旧版《医疗器械临床试验质量管理规范》,从临床试验准备阶段、受试者权益保障、质量管理体系构建3个方面解读新版法规,帮助从业人员更好地理解和依从新版法规。结合新版法规内容变化和医疗器械临床试验中存在的问题,从申办方、研究者、机构办、伦理的角度提出改进建议,进一步提高医疗器械临床试验的质量。By comparing the new version and the old version of Standard for Quality Management of Medical Device Clinical Trials,this paper interpreted the new edition of regulations from three aspects:the preparation stage of clinical trials,the protection of subjects’interests,and the construction of quality management system,so as to help practitioners better understand and comply with the new regulation.Combined with the changes of the new regulation and the problems existing in clinical trials of medical devices,the improvement measures were proposed from the perspective of sponsor,researchers,institutional offices and ethics,so as to further improve the quality of clinical trials of medical devices.

关 键 词：医疗器械 临床试验 新版法规 试验准备 受试者权益 质量管理体系 

分 类 号：R197.39[医药卫生—卫生事业管理]