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蒲公英 - 制药技术的传播者 GMP理论的实践者»蒲公英論壇 › 醫療器械 › 生産/質量 › 三类醫療器械生产许可申請按照哪个文件执行？

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三类醫療器械生产许可申請按照哪个文件执行？

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发表于 2025-3-3 15:11:41 | 只看該作者回帖奖励

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各位老师，我第一次做醫療器械，是个三类醫療器械，需要报生产许可，应该按照国家哪个文件执行申請程序？申請表在哪里下载？需要哪些材料？

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沙發

发表于 2025-3-3 15:14:14 | 只看該作者

醫療器械生产监督管理办法

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板凳

发表于 2025-3-3 15:16:50 | 只看該作者

一般在市局级别的政务网，有申請，拿自己账号登陆看看，浙江是这样

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地板

发表于 2025-3-3 15:58:11 | 只看該作者

哪個省的？

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5^#

发表于 2025-3-3 16:29:12 | 只看該作者

歲寒三友发表于 2025-3-3 15:16
一般在市局级别的政务网，有申請，拿自己账号登陆看看，浙江是这样

二，三类生产许可在省局申請

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6^#

发表于 2025-3-3 16:31:49 | 只看該作者

去国家药监局醫療器械审评中心 https://www.cmde.org.cn/sqrzc/zxfw/lcjtcn/index.html

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7^#

发表于 2025-3-4 15:31:21 | 只看該作者

thinkpower 发表于 2025-3-3 16:31
去国家药监局醫療器械审评中心 https://www.cmde.org.cn/sqrzc/zxfw/lcjtcn/index.html

大哥，你这是拿注冊证，人家问的是生产许可。三类生产许可应该是找省局。

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你就不怕他是个小白，注冊证都没报过发表于 2025-3-4 15:33

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8^#

发表于 2025-3-5 11:55:57 | 只看該作者

找屬地的省藥監局官網，有申辦資料要求及模板。

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