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Recognised Standards for Certification

What recognised standards are​

Recognised standards (θͺθ¨ΌεŸΊζΊ– β€” ninsho kijun) are standards designated by MHLW as acceptable benchmarks for Ninsho certification. They specify the technical, performance, and safety requirements that a device in a particular category must meet to be eligible for certification by an RCB.

Recognised standards include:

  • International standards β€” ISO and IEC standards adopted directly or with Japanese modifications (e.g. ISO 13485, IEC 60601 series, ISO 10993 series)
  • Japanese Industrial Standards (JIS) β€” Japan-specific standards developed by JSA (Japanese Standards Association), often harmonised with ISO/IEC

The MHLW-designated standards list​

MHLW publishes and periodically updates the list of recognised standards. The list specifies:

  • The JMDN code(s) for device types to which the standard applies
  • The standard number and title
  • Whether conformity to the standard is sufficient for Ninsho, or whether additional requirements apply

If your device type is on the list, Ninsho via an RCB is the typical pathway. If not, Shonin is required.

The current list is available at mhlw.go.jp (Japanese language).

How standards relate to JMDN codes​

Each entry on the recognised standards list is linked to specific JMDN codes. When you have identified your device's JMDN code, you can cross-reference it against the standards list to determine:

  1. Whether a recognised standard exists for your device type
  2. Which specific standard(s) apply
  3. Whether the standard is directly applicable or requires modification

What to do when no recognised standard exists​

If no recognised standard covers your device type, Ninsho is not available β€” you must use Shonin. If you believe a standard should be designated but has not yet been, there is a formal process to petition MHLW for new standard designation, but this is a lengthy process that is not suitable for near-term market access planning.