PMDA vs TGA: Medical Device Regulatory Comparison
Compare the medical device registration pathways, classification, and regulatory requirements of PMDA (Japan) vs TGA (Australia).
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
TGA
Therapeutic Goods Administration (Australia)
Australia
The TGA regulates medical devices in Australia under the Therapeutic Goods Act 1989. Australia uses a risk-based classification system aligned with GHTF/IMDRF. The TGA is an MDSAP participating author…
Class I, IIa, IIb, III, AIMD
ARTG inclusion via conformity assessment
- ▸ARTG registration
- ▸Conformity assessment
- ▸MDSAP participation
- ▸Adverse event reporting
- ▸Post-market surveillance
MedFlux monitors both PMDA and TGA in real time — every regulatory change, safety alert, and market signal delivered in under 90 seconds.
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