Ministerial Ordinance Amending Enforcement Regulations on Pharmaceuticals and Medical Devices
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施行規則の一部を改正する省令
Published: 2017-01-25 · Source: e-Gov Law Search — Updated Laws · Stage: Promulgated · Area: Healthcare / Pharmaceuticals · Impact (preliminary): Medium · First detected by this dashboard: 2026-09-09
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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. 2 of 2017 was promulgated on 2017-01-25. It amends the Enforcement Regulations of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, issued as Ministry of Health and Welfare Ordinance No. 1 of 1961; the metadata does not specify the amended provisions or effective date.
Business Impact
Businesses dealing in pharmaceuticals and medical devices may be affected by changes to the enforcement regulations governing their quality, efficacy and safety, but the metadata does not identify the specific requirements changed.
Recommended Action
Review of the official Japanese ordinance could clarify the amended provisions, their scope and the effective date.