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CATEGORY: REGULATORY PATHWAYS
Shonin (Japan Pre-Market Approval)
The PMDA/MHLW pre-market approval pathway for Class II (without standard), III, and IV medical devices in Japan. Shonin involves PMDA scientific review followed by MHLW formal approval.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
WHEN IT APPLIES
Shonin is Japan’s PMDA/MHLW pre-market approval path for higher-risk devices (typically Class III/IV and some Class II without standards).
PROCESS / STEPS
- Confirm Japanese classification and pathway (Shonin vs Ninsho vs Todokede).
- Engage a DMAL holder.
- Prepare dossier and consult PMDA as needed.
- Complete review and MHLW authorization; plan PMS.
EXAMPLES
- A novel implant without a certification standard typically requires Shonin rather than Ninsho.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to Shonin (Japan Pre-Market Approval) across 27 authorities in real time.
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