JAAME Legal Affairs Committee Regulatory Affairs Subcommittee notification regarding cybersecurity and usability requirements for medical devices, issued January 29, 2024, providing guidance on applicable standards and compliance procedures.

JAAME Technical Committee EMC Subcommittee notice (November 2023) regarding METI's published examples of radiofrequency emissions from mobile telecommunications devices, relevant to electromagnetic compatibility assessment of medical devices.

JAAME Clinical Evaluation Committee guidance documents (May 2, 2023) providing comprehensive instructions for preparing clinical evaluation reports and consultation materials, including acceptance criteria and fundamental requirements for regulatory submissions.

JAAME Sales and Maintenance Committee guideline (May 8, 2023) providing infection prevention measures and operational protocols for medical device distribution and service sectors during pandemic conditions.

JAAME Clinical Evaluation Committee documentation examples (November 1, 2022) illustrating proper clinical evaluation report formatting and content based on the 2020 guidance on clinical evaluation report and consultation material preparation.

JAAME SaMD Regulatory Response Sub-working Group presentation summarizing Class I SaMD product handling procedures, classification criteria, and regulatory compliance requirements for software-based medical device manufacturers.

JAAME interpretive guidance (Version 1.0, October 20, 2022) clarifying software medical device applicability determinations and classification procedures to facilitate manufacturer understanding of regulatory requirements.

JAAME PMS Committee announcement (June 1, 2022) establishing inquiry procedures and publishing frequently asked questions regarding GS1-128 barcode reading applications for medical device identification and traceability purposes.

Announcement of METI Healthcare Industry Division's new web portal providing consolidated information on past support programs, research reports, and government agency consultation services for healthcare industry internationalization.

Video viewing platform for PMDA collaborative plan training program (FY2021) covering marketing approval review procedures, regulatory requirements, and best practices for medical device manufacturers and regulatory professionals.