Recommendation against 医療機器産業連合会、AMDD、EBC

医療機器産業連合会、AMDD、EBC (Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices)
Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesMinistry of Health, Labour and Welfare

Action summary

Company
Original: 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

Machine-translated summary — verify against original

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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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
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About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.