Recommendation against 医療機器産業連合会、AMDD、EBC
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
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。
Source
Original Ministry of Health, Labour and Welfare announcement (in Japanese)The original Japanese disclosure is the authoritative record.
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Language
日本語版を見る (Japanese)Company info
- English name
- 医療機器産業連合会、AMDD、EBC Japanese only
- Japanese name
- 医療機器産業連合会、AMDD、EBC
About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.