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CATÉGORIE: REGULATORY PATHWAYS

Ninsho (Certification tierce Japon)

Une voie réglementaire pour les dispositifs de Classe II au Japon conformes à une norme de certification publiée, évalués par un organisme de certification enregistré (RCB).

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

Ninsho is third-party certification in Japan for many Class II devices that conform to published certification standards (Ninsho Kijun), reviewed by an RCB rather than full PMDA Shonin review.

PROCESS / STEPS

  1. Verify a certification standard exists for the device.
  2. Select a Registered Certification Body.
  3. Submit certification package and close findings.
  4. Maintain post-certification change control with the DMAL.

EXAMPLES

  • Certain controlled Class II devices with clear standards use Ninsho for faster market access than Shonin.

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TERMES CONNEXES

Shonin (Approbation pré-commercialisation Japon)