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 WelfareOctober 7, 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
October 7, 2024
Issuing authority
Ministry of Health, Labour and Welfare
厚生労働省

Violation

Machine-translated summary — verify against original

We are working on expanding the PMDA's review system. We also aim to further promote the practical use of innovative medical devices.

Show original Japanese text

PMDAの審査体制の拡充といったものを進めているところでございます。我々もより一層、こういった新規性のある医療機器の実用化促進を図ってまいりたいと考えております。

Source

Original Ministry of Health, Labour and Welfare announcement (in Japanese)

The original Japanese disclosure is the authoritative record.

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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.