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關于MDR程序重大變化的公告

關于MDR程序重大變化的公告

自 2021 年 5 月 26 日起,根據 93/42/EEC 指令指定的認可機構將不能再進行首次認證,但NANDO已公布,根據MDR 2017/745/EU第120條

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MDR程序的法律通知

MDR程序的法律通知

您可以查看我們新發布的《醫療器械安排程序公告通知》的詳細信息。

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MDR 過渡流程

根據(EU)2023/607法規,只要滿足某些條件,MDD證書的有效期將被延長。點擊這里獲取詳細信息。

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UDEM Certificate

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