Health Canada vs PMDA: Medical Device Regulatory Comparison
Compare the medical device registration pathways, classification, and regulatory requirements of Health Canada (Canada) vs PMDA (Japan).
Health Canada
Health Canada — Therapeutic Products Directorate
Canada
Health Canada regulates medical devices through a four-class risk-based system. Class I devices require an establishment license, while Class II-IV require pre-market review. Canada is an MDSAP partic…
Class I, II, III, IV
MDEL (Class I), MDL (Class II-IV)
- ▸Medical Device License (MDL)
- ▸MDSAP single audit program
- ▸Incident reporting via MEDDEV
- ▸Medical Device Establishment License (MDEL)
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
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