国家药监局:今日起,将试点启用医疗器械电子注册证!

2020-11-02 国家药监局 国家药监局

日前,国家药监局发布关于试点启用医疗器械电子注册证的公告,自2020年10月19日至2021年8月31日,试点启用医疗器械电子注册证,试点发放范围为自公告之日起新批准的国产第三类、进口第二、三类首次注

日前,国家药监局发布关于试点启用医疗器械电子注册证的公告,自2020年10月19日至2021年8月31日,试点启用医疗器械电子注册证,试点发放范围为自公告之日起新批准的国产第三类、进口第二、三类首次注册的医疗器械注册证。

为贯彻落实国务院关于深化“放管服”改革、优化营商环境、推进“互联网+政务服务”工作的重要决策部署,为企业提供更加高效便捷的政务服务,经研究决定,自2020年10月19日起,试点启用医疗器械电子注册证。现将有关事项公告如下:

一、试点时间为2020年10月19日至2021年8月31日。

二、试点发放范围为自公告之日起新批准的国产第三类、进口第二、三类首次注册的医疗器械注册证,注册变更与延续注册将视情况逐步发放。

三、试点期间,医疗器械电子注册证与纸质医疗器械注册证同步发放。医疗器械电子注册证与纸质医疗器械注册证具有同等法律效力。

四、医疗器械电子注册证不包含本产品技术要求。

五、企业须先行在国家药监局网上办事大厅注册并实名认证,方可进入网上办事大厅“我的证照”栏目,查看下载医疗器械电子注册证。也可登录“中国药监APP”,查看医疗器械电子注册证。

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    2020-11-04 xuyu
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    2020-11-04 zhyy93
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    2020-11-03 474576351

    不错

    0

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