MHLW Ministerial Ordinance amending standards for post-marketing medical device studies and trials
医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律等の一部を改正する法律の一部の施行に伴う厚生労働省関係省令の整備等に関する省令
Published: 2026-09-30 · Source: e-Gov Law Search — Updated Laws · Stage: Scheduled to Take Effect · Area: Healthcare / Pharmaceuticals · Impact (preliminary): Medium · First detected by this dashboard: 2026-10-20
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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
Ministry of Health, Labour and Welfare Ordinance No. 142 of 2026 was promulgated on 2026-09-30, with an effective date of 2027-05-20, to adjust ministry ordinances in connection with partial implementation of an Act amending legislation on the quality, efficacy and safety of pharmaceuticals and medical devices. The listed amendment concerns the Ministerial Ordinance on Standards for Conducting Post-Marketing Studies and Trials of Medical Devices (Ministry of Health, Labour and Welfare Ordinance No. 38 of 2005).
Business Impact
Medical device companies conducting post-marketing studies and trials may be affected by changes to the applicable standards; the supplied information does not identify the amended requirements.
Recommended Action
Reviewing the official Japanese amendment and target ordinance would help clarify the revised provisions, their application from 2027-05-20 and any transitional arrangements.
Timeline of related official records
Related official records are linked only when names and instrument numbers match exactly, so this timeline may be incomplete. Dates are as stated by the official sources. It is a monitoring aid, not legal advice; the original Japanese sources are authoritative.
- 2026-09-30 — Promulgated (instrument recorded by e-Gov Law Search) Original Japanese source
- 2027-05-20 — Effective date stated by e-Gov Law Search Original Japanese source