PMDA posts revised medical device adverse event terminology list (Part 4), based on IMDRF terms
「IMDRF不具合用語集を踏まえた医療機器不具合用語集の改訂について（その4）」を掲載しました
Published: 2026-01-09 · Source: Pharmaceuticals and Medical Devices Agency (PMDA) — Safety Updates · Stage: Government Announcement · Area: Healthcare / Pharmaceuticals · Impact (preliminary): Medium · First detected by this dashboard: 2026-08-06
View the original Japanese source More Healthcare / Pharmaceuticals updates Search all updates in the dashboard
AI summary
Generated by AI from the Japanese source metadata. It is an unofficial monitoring aid, not legal advice, and may contain errors. The area, stage, and impact labels are preliminary keyword-based triage labels. Confirm every point in the original Japanese source.
Summary
The Pharmaceuticals and Medical Devices Agency (PMDA) published a notice dated 2026-01-09 on its safety updates page, titled as the revision of the medical device malfunction/adverse event terminology list in light of the IMDRF terminology (Part 4). Only the title and a generic source label are provided, so the specific changes are not known from the metadata.
Business Impact
Medical device manufacturers or marketing authorization holders that report malfunctions or adverse events in Japan may need to check whether the revised terminology affects how they code or describe such reports. The scope and any timing of application cannot be determined from the provided information.
Recommended Action
Review the official PMDA page and the revised terminology list in Japanese to confirm what changed and whether it is relevant to your reporting practices.