NMPA ChinaFDA USA EU MDR / IVDRMedical Devices & IVDs

Global Medical Device Regulation Tracker

One-stop tracker for medical device and in vitro diagnostic (IVD) regulatory developments across China (NMPA), the United States (FDA), and the European Union (MDR/IVDR): new regulations, public consultations, guidance documents, standards updates, and key compliance deadlines.

Last updated: 2026-09-22 Entries tracked: 0 Update frequency: Weekly

中文版 (Chinese version) ↗

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NMPA updates
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IVD-related

Regulatory Updates

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Official Sources

Authoritative primary sources — all updates on this site are tracked from these channels

NMPA Device Announcements

NMPA medical device notices and announcements (standards, registration, classification)

nmpa.gov.cn →

CMDE (NMPA Review Center)

Technical review guidance — publication and public consultation

cmde.org.cn →

CMDE IVD Guidelines

IVD reagent guidelines and common questions

CMDE Guidelines →

FDA CDRH Guidance

Center for Devices and Radiological Health guidance documents (by year)

fda.gov →

Federal Register

Final rules and proposed rules (e.g., IVD reclassification)

federalregister.gov →

EU MDCG Guidance

Medical Device Coordination Group guidance (MDR/IVDR implementation)

DG SANTE →

EUR-Lex Official Journal

Official EU legal texts (MDR 2017/745, IVDR 2017/746 and amendments)

eur-lex.europa.eu →

EUDAMED Database

EU device database: SRN registration, UDI/device registration deadlines

EUDAMED →