Administrative Guidance against 医療機器産業連合会(医機連)

医療機器産業連合会(医機連) (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
Original: 医療機器産業連合会(医機連)
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

Development of human resources for medical devices, streamlining regulations, international regulatory harmonization, improving certification systems, cybersecurity measures, rationalizing QMS, enhancing registry reliability, promoting work style reforms, advancing electronic applications and digitization, and strengthening collaboration with overseas regulatory authorities.

Show original Japanese text

医療機器の人材育成、規制の合理化、国際規制調和、認証制度の改善、サイバーセキュリティ対策、QMSの合理化、レジストリの信頼性向上、働き方改革の推進、電子申請・電子化の促進、海外規制当局との連携強化。

Source

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

The original Japanese disclosure is the authoritative record.

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Company info

English name
医療機器産業連合会(医機連) Japanese only
Japanese name
医療機器産業連合会(医機連)
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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.