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各省、自治区、直辖市和新疆生产建设兵团药品监督管理局：
为加强医疗器械（含体外诊断试剂）注册管理，规范注册申请人注册自检工作，确保医疗器械注册自检工作有序开展，根据《医疗器械监督管理条例》（国务院令第739号）及配套规章要求，国家药品监督管理局组织制定了《医疗器械注册自检核查指南》，现印发给你们，自发布之日起施行。
国家药监局综合司
2025年9月12日
【如需下载原文，请扫描下方二维码】
【NMPA】国家药监局综合司关于印发医疗器械注册自检核查指南的通知 药监综械注函〔2025〕499号
来源 NMPA
作者 CIRS
扫描下方的二维码订阅“CIRS医械合规动态”！实时传递最新医疗器械监管法规动态，分享医疗器械注册成功经验及经典案例跟踪医疗器械最新产品安全与法规监管动态，获得最新一手资讯。
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