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When to Switch from Ninsho to Shonin

Triggers that require upgrading to Shonin​

A device that was originally certified via Ninsho may need to switch to Shonin if:

Post-certification device change. The MAH makes a design or materials change that takes the device outside the scope of the recognised standard it was certified to. In this case, the MAH must file an Ichibu Henko (partial change) application — but if the change is substantial and the device is no longer within any recognised standard's scope, the change application must go to MHLW as a Shonin rather than to the RCB.

Standard scope narrowed. MHLW updates a recognised standard in a way that excludes the device's current design or materials. The MAH must either modify the device to come back within scope, or switch to Shonin.

MHLW re-classification. MHLW reclassifies the device type from Class II to Class III, and the new Class III designation does not include a Ninsho-eligible pathway.

RCB finds non-conformity. During a surveillance audit, the RCB identifies that the device no longer conforms to the standard. Depending on severity, this may require either corrective action and re-audit, or withdrawal and re-application via Shonin.

Process for transitioning from Ninsho to Shonin​

  1. Confirm with PMDA (via pre-submission consultation) that Shonin is required and what data package PMDA expects
  2. Prepare the Shonin dossier — this will typically require more data than the original Ninsho application (particularly for clinical evidence and manufacturing details)
  3. Submit the Shonin application to PMDA
  4. Maintain the existing Ninsho certification while the Shonin application is under review (where possible and permissible)
  5. Upon Shonin issuance, cancel the Ninsho certification with the RCB

The transition period needs careful management to avoid market access gaps.