Enforcement record
Recommendation disclosure naming 医機連、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: May 4, 2026, 09:02 PM JST
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Action summary
- Company
- 医機連、AMDD、EBCJapanese onlyOriginal: 医機連、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
The recommendation addresses issues such as the construction of a medical device database, mandatory registration of UDI information, utilization of medical data, activation of clinical research, improvement of device waste, review of advertising regulations, strengthening of cross-border e-commerce regulations, compliance with environmental regulations, streamlining export procedures, and review of business practices and QMS systems.
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、臨床研究の活性化、デバイスロスの改善、広告規制の見直し、越境ECの規制強化、環境規制への対応、輸出手続きの効率化、業態とQMS制度の見直しなど。
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.