The MHLW Radio Wave Utilization Portal has released the FY2025 survey report on the impact of radio waves on medical devices. This report presents findings from comprehensive investigations conducted by the EMC subcommittee regarding electromagnetic compatibility and radio wave interference with medical device operations.

English translation of the August 2025 research report on regulatory review considerations for AI-based SaMD. This publication provides comprehensive guidance on assessment methodologies and regulatory pathways for software medical devices incorporating artificial intelligence technologies.

JFMDA has revised the medical device defect terminology glossary. Updates include harmonization of individual terminology with IMDRF adverse event terminology standards to ensure consistency and clarity in defect reporting and classification across regulatory frameworks.

Alert for medical devices running embedded Windows (Standard Edition 8 or later) with Secure Boot functionality enabled. Device manufacturers should verify secure boot certificate validity and plan for potential renewal to prevent operational disruptions in 2025.

JFMDA Law and Regulations Committee report on regulatory considerations for AI-based SaMD from October 2022. This working group study addresses assessment frameworks, regulatory pathways, and compliance requirements specific to medical devices incorporating artificial intelligence technologies.

Published December 25, 2024, this guidance document from JFMDA's Personal Information Handling Team provides industry guidance on leveraging anonymized information for developing AI-based medical devices while maintaining regulatory compliance and data privacy requirements.

Issued September 24, 2024, by JFMDA's SaMD Regulatory Compliance Working Group, this document provides example scenarios and considerations for staged approval pathways applicable to disease diagnostic software medical devices under updated regulatory frameworks.

English version of JFMDA Law and Regulations Committee's notification on cybersecurity and usability requirements for medical devices, published January 29, 2024. Provides guidance on regulatory expectations for device security and user interface safety.

November 2023 notice from JFMDA's Technical Committee EMC Subcommittee regarding MHLW publication of representative radio wave examples from mobile communication devices, supporting medical device electromagnetic compatibility assessments.

Overview of handling procedures for SaMD Class I products. This document summarizes materials presented during the 2022 SaMD regulatory compliance seminar as an activity report by the SaMD Regulation Response Sub-Working Group.