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真实世界数据用于医疗器械临床评价技术指导原则（试行）

2020-11-26 国家药品监督管理局药品审评中心（CDE） NMPA

真实世界研究

　为规范和指导真实世界数据在医疗器械临床评价中的应用，按照国家药品监督管理局中国药品监管科学行动计划工作安排，国家药监局组织制定了《真实世界数据用于医疗器械临床评价技术指导原则（试行）》，现予发布。

中文标题：

真实世界数据用于医疗器械临床评价技术指导原则（试行）

发布机构：

国家药品监督管理局药品审评中心（CDE）

发布日期：

2020-11-26

简要介绍：

　为规范和指导真实世界数据在医疗器械临床评价中的应用，按照国家药品监督管理局中国药品监管科学行动计划工作安排，国家药监局组织制定了《真实世界数据用于医疗器械临床评价技术指导原则（试行）》，现予发布。

　　特此通告。

　

　　                                国家药监局                 

　　                             2020年11月24日   

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    2022-01-04 一己怀

    国家药监局

    0

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    2021-05-16 ms123

    学习

    0

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    2020-12-28 ms5000000986931241

    好

    0

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    2020-11-27 1211c54em14(暂无昵称)

    好好研究

    0

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    2020-11-27 392534278

    学习

    0

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