On September 30th, Japan’s Ministry of Health, Labour and Welfare made an announcement that the Japanese standard JIS T 62366-1 (Application of usability engineering to medical devices) has been amended to comply with JIS T 14971 (Application of risk management to medical devices).

Manufacturers and its designated authorized representatives shall confirm Article 9 and Article 16 of the Essential Principles where engineering usability is related. This announcement applies from October 1st of 2022, and grace time of compliance is given until March 31st of 2024.