On March 31st, 2023, the Japanese MHLW has issued an additional notification to compliment the "Notification No. 67 of the Ministry of Health, Labor and Welfare."
The Notification No. 67 adds that now every medical device with software is required to comply with the new Article 12 of the Essential Principles to have a proper cybersecurity system.
The purpose of this additional notification is to give clearer definitions to each term / wording to match the Japanese new Essential Principles with the IMDRF guidance “Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices” and the “Principles and Practices for Medical Device Cybersecurity.”
- No. 67 Notification by MHLW about Cybersecurity and Essential Principle
- Additional explanation by MHLW to No. 67 Notification about Cybersecurity