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1月17日,医疗器械国际监管法规研究组第十四次会议在北京召开。国家食品药品监督管理总局副局长焦红出席会议并讲话。会上,总局器械注册司介绍了总局医疗器械国际监管法规研究进展和参加国际医疗器械监管机构论坛(IMDRF)第十次管理委员会会议的情况。医疗器械国际监管法规研究组的9个研究小组汇报了跟踪和参与IMDRF工作项目情况,内容涉及医疗器械注册申报资料规范、医疗器械良好审查规范、医疗器械生命周期内通用数据元素、医疗器械独立软件、医疗
January 17, the fourteenth meeting of the International Regulatory Commission on Medical Device Research was held in Beijing. Jia Hong, deputy director of the State Food and Drug Administration, attended the meeting and delivered a speech. At the meeting, the Department of Device Registration of the General Administration introduced the progress made by the General Administration of International Medical Device Regulations and the attendance of the tenth meeting of the IMDRF. Nine research groups of the International Regulatory Research Group on Medical Devices reported tracking and participating in the IMDRF project, covering the specification of medical device registration declarations, the good review of medical devices, the common data elements in the medical device life cycle, the medical device independent software Medical