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![broken image](http://user-assets.sxlcdn.com/images/171803/Fr8k0T31JI7OkY2ITH4Q7BR29hOk.png?imageMogr2/strip/auto-orient/thumbnail/1200x9000>/quality/90!/format/png)
为提高医疗器械技术审评的规范性和科学性,指导医疗器械注册人/备案人编写产品技术要求,根据《医疗器械监督管理条例》及《医疗器械注册与备案管理办法》《体外诊断试剂注册与备案管理办法》的规定,国家药品监督管理局组织修订了《医疗器械产品技术要求编写指导原则》,现予发布。
特此通告。
附件:医疗器械产品技术要求编写指导原则
国家药监局
2022年2月8日
![broken image](http://user-assets.sxlcdn.com/images/171803/Fn20K9vOcSLhlrxcdRC7HwEOFaOt.jpg?imageMogr2/strip/auto-orient/thumbnail/1200x9000>/quality/90!/interlace/1/format/jpeg)
![broken image](http://user-assets.sxlcdn.com/images/171803/Fg2j-gzrbru_W8_HN-mtLVDMHVXS.jpg?imageMogr2/strip/auto-orient/thumbnail/1200x9000>/quality/90!/interlace/1/format/jpeg)
![broken image](http://user-assets.sxlcdn.com/images/171803/Fn0dunj7zMAHWgaigswFmY01kK3i.jpg?imageMogr2/strip/auto-orient/thumbnail/1200x9000>/quality/90!/interlace/1/format/jpeg)
![broken image](http://user-assets.sxlcdn.com/images/171803/FuVbUzslbV04x_PVEk9Muftr0z71.jpg?imageMogr2/strip/auto-orient/thumbnail/1200x9000>/quality/90!/interlace/1/format/jpeg)
![broken image](http://user-assets.sxlcdn.com/images/171803/Fi42iMc1ZFufBTBHd4cUNJxdAYSy.jpg?imageMogr2/strip/auto-orient/thumbnail/1200x9000>/quality/90!/interlace/1/format/jpeg)
![broken image](http://user-assets.sxlcdn.com/images/171803/FrLBNfb7tOBjTxPiVQdyuGqRq0OP.jpg?imageMogr2/strip/auto-orient/thumbnail/1200x9000>/quality/90!/interlace/1/format/jpeg)
![broken image](http://user-assets.sxlcdn.com/images/171803/FhjwQf-lcrc9Jw02plQ37EdGLF7A.jpg?imageMogr2/strip/auto-orient/thumbnail/1200x9000>/quality/90!/interlace/1/format/jpeg)
![broken image](http://user-assets.sxlcdn.com/images/171803/Ftz0dNG8Up6o_feW0HgZxuo1XyVM.jpg?imageMogr2/strip/auto-orient/thumbnail/1200x9000>/quality/90!/interlace/1/format/jpeg)
![broken image](http://user-assets.sxlcdn.com/images/171803/FuFP0aeXtk4a3qxtphmIe8TI-yMg.jpg?imageMogr2/strip/auto-orient/thumbnail/1200x9000>/quality/90!/interlace/1/format/jpeg)
![broken image](http://user-assets.sxlcdn.com/images/171803/Fr-HuXUvhErAjKsx8K9Kyp_fDPkP.jpg?imageMogr2/strip/auto-orient/thumbnail/1200x9000>/quality/90!/interlace/1/format/jpeg)
延伸阅读
![broken image](http://user-assets.sxlcdn.com/images/171803/FoGz0GJr8z25h7hDUg_6FadPqpEr.png?imageMogr2/strip/auto-orient/thumbnail/1200x9000>/quality/90!/format/png)
为提高医疗器械技术审评的规范性和科学性,指导医疗器械注册人/备案人编写产品技术要求,根据《医疗器械监督管理条例》及《医疗器械注册与备案管理办法》《体外诊断试剂注册与备案管理办法》的规定,国家药品监督管理局组织修订了《医疗器械产品技术要求编写指导原则》,现予发布。
特此通告。
附件:医疗器械产品技术要求编写指导原则
国家药监局
2022年2月8日
延伸阅读