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Application Process and Timelines

Documentation requirements for Ninsho​

The Ninsho application dossier demonstrates conformity with the applicable recognised standard(s). Required documents include:

  • Application form (RCB-specific format, based on MHLW template)
  • Device description and specification
  • Summary of conformity with each clause of the applicable standard
  • Test reports and supporting data for each standard clause
  • Biocompatibility data (ISO 10993)
  • Labelling draft (Japanese)
  • Manufacturing information and FMR reference
  • QMS confirmation (MO 169 compliance declaration)

Unlike Shonin, Ninsho does not require a full clinical evaluation report in most cases — standard conformity with performance testing data is typically sufficient for standard Class II devices.

RCB review process​

Step 1 — Document submission. MAH submits the complete dossier to the RCB.

Step 2 — Completeness check. RCB verifies all required documents are present and in acceptable format.

Step 3 — Technical review. RCB reviewers evaluate conformity with the applicable standard. This may involve requests for additional data or clarification.

Step 4 — QMS review. For some device types, the RCB may conduct a QMS review or on-site audit as part of the certification process, though this is less common than in the EU Notified Body system.

Step 5 — Certification decision. If the review is satisfactory, the RCB issues the Ninsho certificate to the MAH.

Typical timelines​

Ninsho timelines are significantly faster than Shonin:

  • Simple, well-documented Class II device (e.g. standard contact lens with established standard): 3–6 months from complete submission
  • More complex Class II device or less straightforward standard conformity: 6–9 months
  • RCBs with high workload may have longer queues — confirm at the time of application

Responding to RCB queries​

RCBs issue queries similar to PMDA Q&As during Shonin review. Prompt, complete responses help avoid timeline extensions. If an RCB query reveals that the device does not fully conform to the applicable standard, you may need to either modify the device or switch to the Shonin pathway.