English translation of the report "Study on the Review of AI-Enabled Software as a Medical Device: Report of Research Results," originally posted in August 2025. Published as "Final Study Report for Review of SaMD utilizing AI_English" by the working group on review of AI-enabled SaMD under the Regulatory System Committee of the Japan Federation of Medical Devices Associations (JFMDA).

JFMDA has revised its Medical Device Malfunction Terminology. Following the revision of the IMDRF adverse event terminology, the mapping of similar terms between the individual terminologies and the IMDRF terminology was checked, and the individual terminologies were also revised in response to requests and questions. The common terminology was likewise revised in line with the IMDRF revision. The MHLW Pharmaceutical Safety Division and PMDA issued administrative notices on this matter dated January 9, 2026. The Version 8 reporting data required for malfunction reports under the Director-General's notification, and the Excel file of the terminology (8th edition) previously provided by JFMDA, are now available from the PMDA website. A briefing session on the new terminology will be held.

For medical devices running Windows under an embedded license agreement, from Windows Embedded 8 Standard onward, that use the Secure Boot function, the expiration of the Secure Boot certificates in June 2026 may have serious impacts, such as the devices no longer being able to receive subsequent security updates or becoming unstable all at once. JFMDA asks readers to read the attached alert and take action. Issued by the Medical Device Cybersecurity WG of the JFMDA Liaison and Coordination Meeting.

In October 2022, the JFMDA Regulatory System Committee set up a working group on review of AI-enabled SaMD under its review-related subcommittee. Its purpose was to discuss the requirements for the review of AI-enabled SaMD (including medical devices that contain software), such as what to describe in the application and which documents are needed, with PMDA review and standards staff, based on the outputs of AMED research on regulation of software medical devices using AI and other advanced technologies and on current review practice, and to improve the transparency of review by publishing the results. This report summarizes the activities of the working group.

On December 25, 2024, Team 1 of the JFMDA Subcommittee on Handling of Personal Information compiled and published the "Guidance for Companies on the Development of AI Medical Devices Using Pseudonymously Processed Information, Version 1.0." On the same date, the Medical Device Evaluation Division of the MHLW Pharmaceutical Safety Bureau issued an administrative notice providing information on the guidance. As explained in Chapter 0 (Background and Purpose) of the guidance, developing AI-enabled medical devices generally requires large volumes of medical data, such as clinical information, images (CT, MRI, etc.), and other non-text information (ECG, EEG, etc.). However, medical information held by medical institutions generally constitutes personal data under the Act on the Protection of Personal Information, and it is usually not collected for the purpose of AI medical device research and development.

Case study collection (published 24 September 2024) prepared by the Japan Federation of Medical Devices Associations (JFMDA, Task Force on the Two-Stage Approval System, Program Medical Device Regulatory Response SWG), building on discussions with the Japan Digital Health Alliance (JaDHA), to promote understanding and appropriate use of the SaMD Rebalance Notification (the notice of 16 November 2023 on the handling of two-stage approval reflecting the characteristics of program medical devices). It covers disease-diagnosis SaMD, the companion volume to a treatment-use version published by JaDHA. The two-stage approval scheme mainly targets SaMD, such as programs that calculate physiological parameters from non-invasive measurements or imaging, that provide reference information whose clinical significance is not yet established; it excludes products where an incorrect result could seriously affect human life or health. The collection presents both applicable and non-applicable examples, intended as a reference for SaMD developers, including venture and IT companies, when planning development strategy and for discussions with regulatory authorities.

Notice (29 January 2024) from the JFMDA Legislative Affairs Committee, Review-Related Subcommittee, announcing unofficial English translations, prepared by the PMDA Office of Medical Devices, of three MHLW notifications concerning medical device cybersecurity and usability: (1) Application of Article 12-3 of the Essential Principles for Medical Devices (PSEHB MDED Notification No. 0331-8, 31 March 2023); (2) Confirmation of compliance with Article 12-3 of the Essential Principles for Medical Devices (PSEHB MDED Notification No. 0523-1, 23 May 2023); and (3) Handling of the revised Japanese Industrial Standard (JIS) on usability engineering requirements for medical devices (PSEHB MDED and CND Notification No. 0930-1, 30 September 2022). The page notes that the translations are provided for reference only and that only the original Japanese texts have legal effect.

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.

JFMDA explanatory document providing detailed guidance on software medical device applicability determination and classification. Clarifies regulatory interpretation for software qualification and classification to support industry compliance and regulatory submissions.