Ministerial Ordinance Amending Medical Device and In Vitro Diagnostic Quality Standards
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 a stated effective date of 2027-05-20. It amends the Ministerial Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Pharmaceuticals (Ministry of Health, Labour and Welfare Ordinance No. 169 of 2004) as part of adjustments to ministry ordinances accompanying partial implementation of an Act amending legislation on the quality, efficacy and safety of pharmaceuticals and medical devices.
Business Impact
Manufacturers of medical devices and in vitro diagnostic pharmaceuticals may be affected by changes to manufacturing control and quality control standards; the listed information does not identify the specific changes.
Recommended Action
Review of the official Japanese ordinance could clarify the amended standards, any transitional provisions and the scope of the stated 2027-05-20 effective date.
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