EU MDR vs NMPA: Europe and China Medical Device Regulation
Compare EU MDR CE marking with NMPA registration — Notified Bodies vs CMDE, UDI requirements, clinical evidence, and post-market surveillance.
EMA
European Medicines Agency
European Union
The EMA coordinates the EU regulatory framework for medical devices under EU MDR 2017/745 and IVDR 2017/746. While Notified Bodies conduct conformity assessments, the EMA and European Commission set p…
Class I, IIa, IIb, III
CE marking via Notified Body
- ▸EU MDR / IVDR framework coordination
- ▸EUDAMED database oversight
- ▸Notified Body designation support
- ▸CE marking pathway
- ▸Vigilance and post-market surveillance
NMPA
National Medical Products Administration (China)
China
China's NMPA regulates medical devices through CMDE (Center for Medical Device Evaluation) technical reviews. China uses a three-class risk-based system. Foreign manufacturers must appoint a Marketing…
Class I, II, III
NMPA Registration (CMDE review)
- ▸CMDE technical review
- ▸MAH (Marketing Authorization Holder) system
- ▸In-country testing requirements
- ▸Clinical trial oversight
- ▸NMPA registration certificates
MedFlux monitors both EMA and NMPA in real time — every regulatory change, safety alert, and market signal delivered in under 90 seconds.
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