Administrative Guidance against PMDA
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
- October 18, 2022
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
Describes efforts such as shortening review periods for medical devices and in vitro diagnostics, introducing an online application system, promoting approval of software medical devices, full-scale operation of MDSAP, and applying for membership in GHWP.
Show original Japanese text
医療機器・体外診断用医薬品の審査期間の短縮、オンライン申請システムの導入、プログラム医療機器の承認促進、MDSAPの本格運用、GHWPへの加盟申請などの取組について説明している。
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.