关于发布《医疗器械分类目录》子目录相关产品临床评价推荐路径的通告（2022年第30号）
发布时间：2022-07-14
为进一步指导注册申请人确定具体产品的临床评价路径，器审中心按照《医疗器械监督管理条例》的有关规定，根据《决策是否开展医疗器械临床试验技术指导原则》等规范要求，基于目前的审评经验以及《医疗器械分类目录》中的子目录01“有源手术器械”、04“骨科手术器械”、07“医用诊察和监护器械”、08“呼吸、麻醉和急救器械”、09“物理治疗器械”、10“输血、透析和体外循环器械”、19“医用康复器械”、21“医用软件”的产品描述、预期用途和品名举例，提出具体产品临床评价的推荐路径。
特此通告。
附件：1.《医疗器械分类目录》子目录01、04、07、08、09、10、19、21相关产品临床评价推荐路径使用说明（下载）
2.《医疗器械分类目录》子目录01“有源手术器械”相关产品临床评价推荐路径（下载）
3.《医疗器械分类目录》子目录04“骨科手术器械”相关产品临床评价推荐路径（下载）
4.《医疗器械分类目录》子目录07“医用诊察和监护器械”相关产品临床评价推荐路径（下载）
5.《医疗器械分类目录》子目录08“呼吸、麻醉和急救器械”相关产品临床评价推荐路径（下载）
6.《医疗器械分类目录》子目录09“物理治疗器械”相关产品临床评价推荐路径（下载）
7.《医疗器械分类目录》子目录10“输血、透析和体外循环器械”相关产品临床评价推荐路径（下载）
8.《医疗器械分类目录》子目录19“医用康复器械”相关产品临床评价推荐路径（下载）
9.《医疗器械分类目录》子目录21“医用软件”相关产品临床评价推荐路径（下载）
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医疗器械技术审评中心
2022年7月14日
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