Recommendation against 臨薬協、AMDD、EBC
臨薬協、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
- 臨薬協、AMDD、EBCJapanese onlyOriginal: 臨薬協、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
Show original Japanese text
体外診のクラス分類の見直し、根拠資料の考え方、添付文書の電子化、規制調和のための協議、管理者資格要件の見直し、責任者の運用改善、QMS調査制度の国際整合化など。
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)About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.