Administrative Guidance against PMDA（医薬品医療機器総合機構）
PMDA（医薬品医療機器総合機構） (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 WelfareAugust 27, 2021
Action summary
- Company
- PMDA（医薬品医療機器総合機構）Japanese onlyOriginal: PMDA（医薬品医療機器総合機構）
- Governing law
- Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices薬機法
- Action type
- Administrative Guidance行政指導
- Action date
- August 27, 2021
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
Machine-translated summary — verify against original
Explanation of the number of approvals and review periods for items related to COVID-19 measures, promotion of early practical use of program medical devices, full implementation of MDSAP, and revisions to the electronic application system.
Show original Japanese text
新型コロナウイルス感染症対策に関する品目の承認件数や審査期間の状況、プログラム医療機器の早期実用化促進、MDSAPの本格施行、電子申請システムの改修等についての説明。
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)Company info
- English name
- PMDA（医薬品医療機器総合機構） Japanese only
- Japanese name
- PMDA（医薬品医療機器総合機構）
About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.