← Alle Begriffe
KATEGORIE: REGULATORY PATHWAYS
Shonin (Japan Marktzulassung)
Das Shonin-Verfahren der PMDA/MHLW für die Marktzulassung von Klasse-II-(ohne Standard), III- und IV-Medizinprodukten in Japan.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our 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 Marktzulassung) across 27 authorities in real time.
START FREE →