PMDA vs ANVISA: Medical Device Regulatory Comparison
Compare the medical device registration pathways, classification, and regulatory requirements of PMDA (Japan) vs ANVISA (Brazil).
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
ANVISA
Agência Nacional de Vigilância Sanitária (Brazil)
Brazil
ANVISA regulates medical devices in Brazil using a four-class risk-based system. Brazil is an MDSAP participating country. ANVISA requires a Brazilian Registration Holder (BRH) for foreign manufacture…
Class I, II, III, IV
ANVISA cadastro (Class I-II) / registro (Class III-IV)
- ▸Device registration (cadastro/registro)
- ▸Brazilian Registration Holder requirement
- ▸MDSAP participation
- ▸GMP (INMETRO) certification
- ▸ANVISA Technical Opinion
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