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King-Lam

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anx 2025-3-27 17:11: King-Lam: 是提交之后审评老师单独告知，省局直接安排人过来
好的，謝謝了

anx 2025-3-27 15:50: 您好，請問一下，您22年那次發補提交自檢報告之前，審評老師有提前說過提交自檢報告的話要重新體考嗎？還是資料提交之後省局才通知體考的？

醫療檢測-覃工 2025-3-6 14:01: 您好，怎么称呼您，我是深圳检测院的覃工（189 0283 3684，VX同号），贵司有产品需要做注册检吗？特别是有源医疗医疗器械的产品。

Cold1 2022-3-10 14:34: 坐標深圳，加我的微信（lwm420482951）

huakai 2022-2-23 16:58: 蟲4c89ebe6: 对，重新又来了一次体考。当时刚好我省出了个自检体考检查的指导原则，他们就按照那个法规一条一条对着检查
檢查通過了嗎？自檢要建立好多體系文件，你們實驗室通過認證了嗎？方便加個微信嗎？我的微信號18538083971，謝謝！我們現在正在摸索自檢的相關要求。

huakai 2022-2-23 14:05: 您好！你們注冊發補走的是自檢嗎？自檢的話又重新體系核查了嗎？

globle001 2021-12-9 07:34

蠡怡良 2021-11-10 16:48

夏至飄雪 2021-8-31 17:50: 蟲4c89ebe6: 大哥，我微信号是Lam-wai-King，看到劳烦加一下我微信，万分感谢
我加你了，你的微信名是三個蟲的嗎

蠡怡良 2021-8-9 12:21

山東小哥 2021-7-19 16:43

globle001 2021-6-24 07:18

山東小哥 2021-6-2 16:26: 蟲4c89ebe6: 明白，了解。非常感谢您的帮助！
客氣了，互相學習

山東小哥 2021-6-2 15:43: 蟲4c89ebe6: 强制性标准更新要补检，那如果是国家推荐性标准（GB/T）或者是YY/T、YY这类标准更新了，那是否一定要根据新的标准进行检验？
推薦性標准是否補充檢驗各地執行有差別，有的省份是要求整改的。如果只是年代號升級對你引用部分無影響你完全可以寫一個說明而不用補充檢驗，同時也可以符合新標准。如果有實質性變化的話你就得補充檢驗了，不然就通不過審評了。

山東小哥 2021-6-2 15:13: 蟲4c89ebe6 : 哥，我想再请教一个问题。医疗器械注册检验报告是否有有效期？我公司的产品13年检验，但产品生产日期是11年，有效期10年，刚好明年就要延续了，我会突然想到这个 ... 你可以参考一下这个法规：食品药品监管总局关于实施《医疗器械注册管理办法》和《体外诊断试剂注册管理办法》有关事项的通知。检验报告是没有有效期的（与被检验产品有效期没有关系），不过你要关注一下你们产品涉及到的强制性标准是不是变了，如果变了你这个报告就无效了，延续一样要发补新标准的补充检验。建议提前申报延续，即使发补应该也来得及 ... ...

globle001 2019-12-16 07:31

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