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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 › 器械注冊 › 産品技術要求

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産品技術要求

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樓主

发表于 2019-9-11 09:08:03 | 只看該作者回帖奖励

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我想請问下，二类的醫療器械，已经拿到注冊检验报告，在技术要求已经盖章定稿的情况下，我交省局的申报资料中，可否修改技术要求（不涉及型号规格、性能指标、检验方法），技术要求再附一份变化对比表及变化原因说明，同时将检验所定稿的技术要求和修改的技术要求交上去？

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沙發

发表于 2019-9-11 09:11:16 | 只看該作者

你的具體看看，比如：産品構成修改也需要修改檢定報告的。具體你得根據省局要求來完成。可以私下先咨詢下省局

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好的，謝謝詳情回複发表于 2019-9-11 09:14

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板凳

樓主| 发表于 2019-9-11 09:14:06 | 只看該作者

yhlzj99 发表于 2019-9-11 09:11
你的具体看看，比如：产品构成修改也需要修改检定报告的。具体你得根据省局要求来完成。可以私下先咨询下省 ...

好的，謝謝

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地板

发表于 2019-9-11 10:35:18 | 只看該作者

個人認爲是不可以更改的，只有省局審查後要求你改才可以

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