PMDA vs AEMPS: Medical Device Regulatory Comparison
Compare the medical device registration pathways, classification, and regulatory requirements of PMDA (Japan) vs AEMPS (Spain).
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
AEMPS
AEMPS — Spain Medical Device Regulatory Authority
Spain
AEMPS is the national regulatory authority responsible for medical device oversight in Spain. It manages device registration, market surveillance, and adverse event reporting within the Europe regulat…
EU MDR classes
AEMPS registration
- ▸Device registration
- ▸Market surveillance
- ▸Adverse event reporting
- ▸Import/export control
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