Recognised Standards List
What the list is
The MHLW-designated recognised standards list specifies the international and Japanese standards that can be used as the basis for Ninsho (certification) pathway applications. A device whose JMDN code appears on the list against an applicable recognised standard is eligible for Ninsho rather than Shonin.
How standards are designated
MHLW designates standards through a formal notification process:
- MHLW (with PMDA input) evaluates proposed standards for designation
- A notification is issued adding the standard to the recognised standards list
- The notification specifies the JMDN codes and device types to which the standard applies
- RCBs are accredited to certify against designated standards within their scope
When an international standard is revised (e.g. a new ISO edition), MHLW issues a new notification designating the updated version and specifying the transition period.
Categories of recognised standards
General safety and performance:
- IEC 60601-1 — General requirements for basic safety and essential performance of electrical medical equipment
- IEC 60601-1 collateral standards (EMC, usability, software, alarms)
- ISO 14971 — Risk management application to medical devices
Biocompatibility:
- ISO 10993-1 — Evaluation and testing within a risk management process
- ISO 10993 series (individual test standards)
Sterilisation:
- ISO 11135 — Ethylene oxide sterilisation
- ISO 11137 series — Radiation sterilisation
- ISO 17665-1 — Moist heat sterilisation
Device-type-specific:
- Numerous standards for specific device categories including contact lenses, hearing aids, orthopaedic implants, dental devices, IVDs, and others
Finding the current list
The current recognised standards list is published by MHLW and updated periodically. The list is available (in Japanese) at:
Always check the current list before selecting a standard for a Ninsho application — standards are added and updated regularly.