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 WelfareSeptember 1, 2024

Action summary

Company: PMDARomanized
Original: 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: September 1, 2024
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省

Violation

Machine-translated summary — verify against original

Accelerated approval and certification processes for medical devices and in vitro diagnostics related to COVID-19, including expedited reviews, web interviews and mail responses, postponement of on-site inspections and switch to document reviews, and strengthening of the review system to prevent infection.

Show original Japanese text

新型コロナウイルス感染症に関する医療機器・体外診断薬の承認・認証、審査の迅速化、WEB面談・郵送対応、実地調査の延期と書面調査への切り替え、感染症対策のための審査体制の強化。

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 Romanized
Japanese name: ＰＭＤＡ

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About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.