Recognised Standards List

What the recognised standards list is

MHLW publishes and maintains the list of recognised standards (認証基準リスト) — the standards designated by MHLW as acceptable for Ninsho (certification) pathway applications. For each recognised standard, the list specifies:

• The standard number and title
• The JMDN codes for device types to which the standard applies
• Any additional requirements or conditions on use of the standard for certification

The list is the primary tool for determining Ninsho eligibility. If your device's JMDN code appears on the list against an applicable recognised standard, Ninsho is generally available.

How to use the recognised standards list

1. Identify your device's JMDN code
2. Search the recognised standards list for your JMDN code
3. Identify the applicable recognised standard(s)
4. Confirm with an accredited RCB that they are scoped to certify against that standard

If your JMDN code does not appear on the list, or appears only against standards your device cannot fully conform to, Shonin is required.

Current standard categories

The recognised standards list includes standards across major device categories:

• General safety: IEC 60601-1 (electrical safety for active devices)
• Biocompatibility: ISO 10993 series
• Sterilisation: ISO 11135, ISO 11137, ISO 17665-1
• Software: IEC 62304 (in combination with other standards)
• Device-specific: Numerous device-type-specific standards (e.g. contact lenses, hearing aids, orthopaedic implants)

Standards under review — keeping current

MHLW updates the recognised standards list when:

• New international standards are published that MHLW decides to designate
• Existing standards are revised and MHLW transitions to the new version
• New device types are added to the list

Subscribe to MHLW update notifications or periodically check the MHLW website to ensure you are using the current version of the list.

Official source

MHLW recognised standards list (Japanese — updated periodically)