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為完善藥品監管信息化標準體系，促進醫療器械監管信息共享和業務協同，國家藥監局依據《醫療器械監督管理條例》《醫療器械生產監督管理辦法》《醫療器械經營監督管理辦法》等法規、規章，組織制訂了《醫療器械生產許可與備案管理基本數據集》《醫療器械經營許可與備案管理基本數據集》2個信息化標準（見附件）。現予發布，自發布之日起施行。
特此公告。
附件：1.醫療器械生產許可與備案管理基本數據集
2.醫療器械經營許可與備案管理基本數據集
國家藥監局
2025年7月28日
國家藥監局關于發布《醫療器械生產許可與備案管理基本數據集》等2個信息化標準的公告 （2025年第75號）
來源 NMPA
作者 CIRS
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相關服務掃描下方的二維碼訂閱“CIRS醫械合規動態”！實時傳遞最新醫療器械監管法規動態，分享醫療器械注冊成功經驗及經典案例跟蹤醫療器械最新產品安全與法規監管動態，獲得最新一手資訊。
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