Standards, Guidance & Notices
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MHLW
Notice
Notice
MHLW-PSEHB-PSD-0210-No.3
Notice on Partial Revision of 'Reporting of Medical Device Defects and Other Incidents' (Notice MHLW-PSEHB-PSD-0210-No.3, February 10, 2026)
Notice (MHLW-PSEHB-PSD-0210-No.3, 10 February 2026) partially revising the attachment to the 2020 notice on Reporting of Medical Device Defects and Other Incidents (No. 0131-1, 31 January 2020). Issued in connection with the 2025 amendment to the PMD Act (Act No. 37 of 2025) and the related 2025 ministerial ordinance (Ordinance No. 117 of 2025), the revision removes known deaths or serious cases involving foreign medical devices and foreign regenerative medicine products from the scope of the 30-day reporting requirement, while newly requiring 15-day reporting for defects in such foreign products that are not readily foreseeable, whose occurrence trend is unclear, or that suggest a risk of harm to public health and hygiene, along with other technical revisions. The notice takes effect on 1 May 2026.
Published: 2026-02-13
JFMDA
Notice
Notice
jfmda_20260109_fuguai
Utilization of the Medical Device Malfunction Terminology
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.
Published: 2026-01-09