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国家药监局发布免于进行临床评价医疗器械目录，涉及123项牙科产品

 
Issuing time:2025-05-13 16:43Author:编辑部
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*图源：国家药品监督管理局

好的牙·讯｜5月13日，国家药监局发布了《免于进行临床评价医疗器械目录（2025年）》，该目录的修订旨在优化医疗器械注册管理工作。根据《医疗器械注册与备案管理办法》（国家市场监督管理总局令第47号），此次修订工作由国家药监局组织进行，并自公布之日起施行。

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*图源：《免于进行临床评价医疗器械目录（2025年）》

新版目录涉及123项牙科产品，其中包括101项二类医疗器械和22项三类医疗器械。目录新增了口腔数字印模仪、临时冠桥、预成聚合物基冠桥材料等产品，并对矫治保持器的产品描述做出修订。

以下为123项牙科产品清单目录：

免于进行临床评价医疗器械目录（2025年）_00.png
*图源：《免于进行临床评价医疗器械目录（2025年）》
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