Administrative Guidance against PMDA
PMDA (医薬品医療機器等法)
医薬品医療機器等法Ministry of Health, Labour and Welfare
Action summary
- Company
- PMDARomanizedOriginal: PMDA
- Governing law
- 医薬品医療機器等法医薬品医療機器等法
- Action type
- Administrative Guidance行政指導
- Action date
- Unknown
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
Machine-translated summary — verify against original
Explanation of revisions to review fees, medical device approval review system, electronic application, UDI, and system improvements such as real-world evidence.
Show original Japanese text
審査手数料の改定、医療機器の承認審査制度、電子申請、UDI、リアルワールドエビデンス等の制度改善について説明
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.