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国家药品监督管理局关于发布用于罕见病防治医疗器械注册审查指导原则的通告(2018年第101号)

时间:2018-10-18       作者:检验视界网      浏览量:11005 次

为贯彻落实中共中央办公厅、国务院办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》(厅字〔2017〕42号),加强医疗器械产品注册管理,进一步提高注册审查质量,鼓励用于罕见病防治医疗器械研发,国家药品监督管理局组织制定了用于罕见病防治医疗器械注册审查指导原则(见附件),现予发布。

  特此公告。

  附件:用于罕见病防治医疗器械注册审查指导原则.doc


国家药监局
2018年10月12日






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