一站式追踪中国 NMPA、美国 FDA、欧盟 MDR/IVDR 的医疗器械与体外诊断（IVD）法规动态：新规发布、征求意见、指南文件、标准更新与关键合规时间节点。 One-stop tracker for medical device and IVD regulatory developments across China (NMPA), the US (FDA), and the EU (MDR/IVDR): new regulations, consultations, guidance, standards, and key compliance deadlines.
按地区筛选，点击「查看来源」跳转官方原文 · Filter by region, click "View source" for the official document
建议收藏的权威一手来源，本站动态均追踪于此 · Authoritative primary sources tracked by this site
国家药监局医疗器械公告与通告（标准、注册、分类界定）NMPA notices and announcements
nmpa.gov.cn →最终规则与拟议规则 Final and proposed rules (e.g., IVD reclassification)
federalregister.gov →欧盟法规原文 MDR 2017/745、IVDR 2017/746 及修订 Official EU legal texts
eur-lex.europa.eu →SRN 注册、UDI/器械注册强制节点 SRN registration, UDI/device registration deadlines
EUDAMED →