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各省、自治區、直轄市和新疆生產建設兵團藥品監督管理局：
為加強醫療器械（含體外診斷試劑）注冊管理，規范注冊申請人注冊自檢工作，確保醫療器械注冊自檢工作有序開展，根據《醫療器械監督管理條例》（國務院令第739號）及配套規章要求，國家藥品監督管理局組織制定了《醫療器械注冊自檢核查指南》，現印發給你們，自發布之日起施行。
國家藥監局綜合司
2025年9月12日
【如需下載原文，請掃描下方二維碼】
【NMPA】國家藥監局綜合司關于印發醫療器械注冊自檢核查指南的通知 藥監綜械注函〔2025〕499號
來源 NMPA
作者 CIRS
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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