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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 › 有源醫療器械有效期研究

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有源醫療器械有效期研究

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樓主

发表于 2020-3-24 15:14:55 | 只看該作者回帖奖励

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注冊的产品只有厂家提供的关键元器件的疲劳性测试报告，不知道就这样一个资料够不够，按照审查指导原则来看好像要老化试验，公司实在没有条件做，求各位大神们指点，小弟感激不尽，抱拳抱拳：）

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沙發

发表于 2020-3-26 08:58:58 | 只看該作者

不夠，公司沒條件的應該可以委外做

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板凳

樓主| 发表于 2020-4-8 13:49:25 | 只看該作者

公子小德发表于 2020-3-26 08:58
不夠，公司沒條件的應該可以委外做

謝謝，謝謝，委外不太可能，笑哭，本人就按照有效期審查指導原則按照同類産品比對交了一份分析報告，好像老師那邊也通過了，希望能給到各位些些靈感

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地板

发表于 2020-5-22 14:39:41 | 只看該作者

wspringfall 发表于 2020-4-8 13:49
谢谢，谢谢，委外不太可能，笑哭，本人就按照有效期审查指导原则按照同类产品比对交了一份分析报告，好像 ...

親，怎麽類比的呀，能給寫思路麽？我也想用這個方法呢。謝謝啦。

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5^#

发表于 2020-5-28 15:43:11 | 只看該作者

wspringfall 发表于 2020-4-8 13:49
谢谢，谢谢，委外不太可能，笑哭，本人就按照有效期审查指导原则按照同类产品比对交了一份分析报告，好像 ...

同類産品對比交一份分析報告就好。這個方法好，是個好思路。

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6^#

发表于 2020-10-26 11:03:45 | 只看該作者

同類産品對比交一份分析報告。這個方法好，是個好思路，可以試試看。

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7^#

发表于 2021-4-20 14:04:20 | 只看該作者

點贊！

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8^#

发表于 2021-11-24 09:17:03 | 只看該作者

jhkj 发表于 2020-10-26 11:03
同類産品對比交一份分析報告。這個方法好，是個好思路，可以試試看。

前提是要有同類産品已上市，創新的産品就沒辦法了

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9^#

发表于 2021-12-3 17:04:27 | 只看該作者

因省而異吧，有些是可以的。只要能提供廠家的驗證報告。

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10^#

发表于 2022-8-14 11:26:39 | 只看該作者

謝謝分享。

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