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国家药监局发布主动脉覆膜支架系统等3项临床试验指导原则

2019-03-05 佚名 国家药监局

主动脉覆膜支架系统生物可吸收冠状动脉药物洗脱支架
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为加强医疗器械产品注册工作的监督和指导，进一步提高注册审查质量，国家药品监督管理局组织制定了《主动脉覆膜支架系统临床试验指导原则》《生物可吸收冠状动脉药物洗脱支架临床试验指导原则》《经导管植入式人工主动脉瓣膜临床试验指导原则》，现予发布。

关于发布主动脉覆膜支架系统等3项临床试验指导原则的通告

（2019年 第8号）

为加强医疗器械产品注册工作的监督和指导，进一步提高注册审查质量，国家药品监督管理局组织制定了《主动脉覆膜支架系统临床试验指导原则》《生物可吸收冠状动脉药物洗脱支架临床试验指导原则》《经导管植入式人工主动脉瓣膜临床试验指导原则》，现予发布。

特此通告。

国家药监局

2019年2月25日

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#插入话题
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    2019-11-12 ms6829001416292975

    #覆膜支架#

    0

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    2019-03-07 xuyu

    #药监局#

    0

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    2019-03-07 circumcision

    #主动脉#

    0

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    2019-03-07 pyaili

    #国家药监局#

    0