← Alle Begriffe
KATEGORIE: REGULATORY PATHWAYS

Ninsho (Japan Drittanbieter-Zertifizierung)

Ein Zulassungsweg für Klasse-II-Medizinprodukte in Japan, die einem veröffentlichten Zertifizierungsstandard entsprechen. Die Prüfung erfolgt durch eine registrierte Zertifizierungsstelle (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.

RELATED GUIDES & TOOLS

SOURCES

Track regulatory signals related to Ninsho (Japan Drittanbieter-Zertifizierung) across 27 authorities in real time.

START FREE →

VERWANDTE BEGRIFFE

Shonin (Japan Marktzulassung)