Administrative Guidance against PMDA
PMDA (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
- PMDARomanizedOriginal: PMDA
- 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
Description of efforts and system improvements related to approval and review periods for medical devices in response to the novel coronavirus infection.
Show original Japanese text
新型コロナウイルス感染症の対応に関して、医療機器の承認や審査期間についての取り組みと制度の改善についての記述。
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.