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CATEGORY: REGULATORY PATHWAYS

Ninsho (Japan Third-Party Certification)

A regulatory pathway for Class II devices in Japan that conform to a published certification standard (Ninsho Kijun). Review is conducted by a Registered Certification Body (RCB) rather than PMDA.

Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · 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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RELATED TERMS

Shonin (Japan Pre-Market Approval)