JFMDA released a report from the General Consumer Medical Device Research Committee on March 23, 2026, addressing the rapidly changing socioeconomic environment and addressing declining birth rates and demographic challenges in the context of medical device accessibility for general consumers.

On March 17, 2026, JFMDA's Startup Co-creation Promotion Office released the Medical Device Industry Innovation Strategy 2.0, outlining collaborative approaches with startups to drive structural transformation in the medical device industry.

English translation of the August 2025 report on regulatory review procedures for AI-enabled SaMD. This translated version facilitates international understanding of Japanese regulatory considerations for AI-integrated medical device software.

JFMDA updated the Medical Device Adverse Event Terminology Glossary, revising individual terminology lists to harmonize with IMDRF adverse event terminology standards and improve consistency across regulatory definitions.

Alert notification for medical device manufacturers using Windows Embedded 8 Standard or later with Secure Boot functionality regarding impending security certificate expiration and required remedial actions.

JFMDA Legal Affairs Committee's AI-enabled SaMD Regulatory Review Working Group published comprehensive research findings beginning October 2022, examining regulatory pathways and approval considerations for AI-integrated medical device software.

On December 25, 2024, JFMDA's Personal Information Handling Subcommittee Team 1 released guidance for companies developing AI-enabled medical devices utilizing anonymized information for research and development purposes.

September 24, 2024 publication by JFMDA's SaMD Regulatory Compliance Working Group providing illustrative case examples based on the phased approval framework for disease diagnosis software as medical devices.

September 4, 2024 survey report on medical device clinical trial implementation status in Japan, addressing historical challenges regarding high costs, delayed subject enrollment, and data quality concerns in the Japanese clinical trial environment.

Website featuring JFMDA's 40th anniversary commemorative initiatives launched in February 2024, including digest videos and resources celebrating the organization's four decades of contribution to the medical device industry.