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24号）
发布时间：2022-06-16
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02“无源手术器械”、03“神经和心血管手术器械”、 05“放射治疗器械”、06“医用成像器械”、16“眼科器械”、18“妇产科、辅助生殖和避孕器械”、20“中医器械”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02、03、05、06、16、18、20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02“无源手术器械”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03“神经和心血管手术器械”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05“放射治疗器械”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06“医用成像器械”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16“眼科器械”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18“妇产科、辅助生殖和避孕器械”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20“中医器械”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6月16日
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