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医疗器械应急审批程序 2021

2022-01-06 国家药品监督管理局药品审评中心（CDE） CDE

应急审批

为有效预防、及时控制和消除突发公共卫生事件的危害，确保突发公共卫生事件应急所需医疗器械尽快完成审批，根据《医疗器械监督管理条例》（国务院令第739号）及《医疗器械注册与备案管理办法》（市场监管总局令第

中文标题：

医疗器械应急审批程序 2021

发布机构：

国家药品监督管理局药品审评中心（CDE）

发布日期：

2022-01-06

简要介绍：

为有效预防、及时控制和消除突发公共卫生事件的危害，确保突发公共卫生事件应急所需医疗器械尽快完成审批，根据《医疗器械监督管理条例》（国务院令第739号）及《医疗器械注册与备案管理办法》（市场监管总局令第47号）、《体外诊断试剂注册与备案管理办法》（市场监管总局令第48号），国家药品监督管理局组织修订了《医疗器械应急审批程序》，现予发布，自发布之日起施行。原国家食品药品监督管理局《关于印发医疗器械应急审批程序通知》（国食药监械〔2009〕565号）同时废止。

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    2022-02-02 屋顶瞄爱赏月

    学习了

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    2022-01-29 ms9000001995137444

    学习执行#学习#

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    2022-01-25 微探

    学习学习

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    2022-01-24 ms4000001513304915

    学习#学习#

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