Administrative Guidance against PMDA

PMDA (医薬品医療機器等法)

医薬品医療機器等法Ministry of Health, Labour and WelfareJuly 29, 2019

Action summary

Company: PMDARomanized
Original: PMDA
Governing law: 医薬品医療機器等法
医薬品医療機器等法
Action type: Administrative Guidance
行政指導
Action date: July 29, 2019
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省

Violation

Machine-translated summary — verify against original

Explanation regarding revision of review fees, approval review and safety measures for medical devices and in vitro diagnostics, system review, certification system, electronic application, real-world evidence, UDI system, and international harmonization of standards.

Show original Japanese text

審査手数料の改定、医療機器・体外診断薬の承認審査や安全対策、制度の見直し、認証制度、電子申請、リアルワールドエビデンス、UDI制度、規格運用の国際整合等についての説明

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 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.