第２３回 医療機器・体外診断薬の承認審査や安全対策等に関する定期意見交換会 議事録 ｜厚生労働省
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第２３回 医療機器・体外診断薬の承認審査や安全対策等に関する定期意見交換会 議事録 ｜厚生労働省
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This page is the proceedings of the 23rd Regular Opinion Exchange Meeting on Medical Device and In Vitro Diagnostic Drug Approval Reviews and Safety Measures held by the Ministry of Health, Labour and Welfare on September 26, 2025. The meeting covered the amended Pharmaceutical Affairs Law's promotion of real-world data utilization in regulatory applications and acceleration of Software as a Medical Device (SaMD) implementation. PMDA achieved its review period targets and continues its fifth medium-term plan focusing on enhanced scientific capabilities and internationalization. Discussions emphasized promoting development of innovative medical devices using AI technology and delivering higher-quality healthcare services to the public.
