Japan: FAQs and Key Points on SaMD – March/April 2026

• 2026-04-28 01:22:14

In alignment with the latest regulatory guidance on SaMD and cybersecurity for network-connected devices, the framework for managing ancillary network infrastructure (such as VPN gateways) has been refined. This includes an extensive definition of responsible matrices, lifecycle security maintenance, and the implementation of proactive security controls to mitigate cyber risks.

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Japan: MHLW Announced Evaluation Items for Next Generation Medical Devices: Breast Cancer Diagnosis Device and SaMD with Behavior Change – July 2022

• 2022-07-26 11:13:22

MHLW announces evaluation items for medical devices that use new technology to speed up the approval process. This time evaluation items for Breast Cancer Diagnosis Device and SaMD with Behavior Change were announced.

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