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  • Device Regulation

New Medical Device Usability Engineering Standard from MHLW

Japan’s ministry of health, labor and welfare (MHLW) requires compliance with the revised JIS by March 31, 2024.

Technician operating diagnostic equipment for a patient.

Usability engineering is now required when submitting applications to the Japanese authority.

IEC 62366-1, the international standard for usability engineering in medical device development, became a JIS standard in 2019 and was revised as JIS T62366-1:2022 in February 2022. The MHLW of Japan requires compliance with the revised JIS by March 31, 2024.

Emergo by UL provides support throughout the usability engineering process:

  • Research – Research user needs to support design input.
  • Analyze – Task analysis, know problem analysis and use-related risk analysis.
  • Design – Develop designs that are intuitive, easy to use and that reduce the risk of use errors.
  • Evaluate – Formative and summative evaluation support at each stage of product development.
  • Training – We offer seminars and workshops upon request.

For any questions or requests regarding usability engineering, please contact us.