Compliance with JIS T 81001-5-1, the Japanese equivalent of IEC 81001-5-1, becomes mandatory today for medical devices in Japan, following the end of a transition period.
Key points
- Manufacturers must follow a secure software development lifecycle.
- Security risk management is required.
- Vulnerability management and security updates are expected.
- The requirement is enforced through Japan’s Essential Principles for medical devices.
UK medical device manufacturers selling into Japan should align software development with IEC 81001-5-1, which also supports UK and EU conformity. Manufacturers should maintain evidence such as a software bill of materials.
Source: Medical device cybersecurity (Ministry of Health, Labour and Welfare, Japan)
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