Enforcement record
Recommendation disclosure naming 医療機器産業連合会、AMDD、EBC
This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.
Action type
Recommendation
Law
Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
Authority
Ministry of Health, Labour and Welfare
Action date
Unknown
Current page: Enforcement record
This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.
Source verification
Public-source and preservation status
- Publishing authority
- Ministry of Health, Labour and Welfare
- Official source URL
- Recorded by RegBase
- Entity match
- Not confirmed; shown under the published name
- Kiroku preservation
- Queued for preservation
- Captured: Apr 27, 2026, 09:02 PM JST
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Action summary
- Company
- 医療機器産業連合会、AMDD、EBCJapanese onlyOriginal: 医療機器産業連合会、AMDD、EBC
- Governing law
- Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices薬機法
- Action type
- Recommendation勧告
- Action date
- Unknown
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
- Industry context
- 医療機器・医薬品
Violation
Construction of a medical device database, mandatory registration of UDI information, promotion of medical data utilization, regulatory harmonization of clinical trials and research, investigation and improvement of device loss, development of guidelines for medical advertising, strengthening of regulations on cross-border e-commerce, response to environmental regulations, international harmonization of QMS surveys, review of business practices, and revision of management qualification requirements.
Show original Japanese text
医療機器データベースの構築、UDI情報登録義務、医療データの利活用促進、臨床試験・研究の規制調和、デバイスロスの調査と改善、医療広告のガイドライン整備、越境ECの規制強化、環境規制への対応、QMS調査の国際整合、業態見直し、管理者資格要件の見直しなど。
Compliance context
MediumA regulator issued a recommendation or formal request for corrective action.
Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising.
Review the facts and follow-up status. This is usually less severe than a suspension or revocation, but still a public enforcement signal.
This context is an operational aid for review workflows, not a credit opinion or legal conclusion.
Language
日本語版を見る (Japanese)About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.