EMA vs PMDA: Medical Device Regulatory Comparison
Compare the medical device registration pathways, classification, and regulatory requirements of EMA (European Union) vs PMDA (Japan).
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
PMDA
Pharmaceuticals and Medical Devices Agency (Japan)
Japan
Japan's PMDA conducts scientific reviews of medical device applications under the PMD Act. Japan uses a four-class system with three pathways: Todokede (notification) for Class I, Ninsho (third-party …
Class I, II, III, IV
Todokede / Ninsho / Shonin
- ▸Shonin pre-market approval
- ▸Ninsho third-party certification
- ▸QMS inspection (MHLW Ordinance 169)
- ▸PMDA consultation (Taimen Joshu)
- ▸Foreign Manufacturer Registration
MedFlux monitors both EMA and PMDA in real time — every regulatory change, safety alert, and market signal delivered in under 90 seconds.
COMPARE LIVE DATA FREE →