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§ ASIA-PACIFIC
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 certification) for Class II, and Shonin (PMDA/MHLW approval) for Class III-IV. Japan is the world's fourth-largest medical device market.
DEVICE CLASSES
Class I, II, III, IV
APPROVAL PATHWAY
Todokede / Ninsho / Shonin
KEY REGULATORY FUNCTIONS
- ▸Shonin pre-market approval
- ▸Ninsho third-party certification
- ▸QMS inspection (MHLW Ordinance 169)
- ▸PMDA consultation (Taimen Joshu)
- ▸Foreign Manufacturer Registration
OFFICIAL WEBSITE
https://www.pmda.go.jp →MedFlux monitors PMDA regulatory changes, safety alerts, and market signals in real time — so your team never misses a critical update.
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