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 contains the minutes of the 23rd Regular Opinion Exchange Meeting on Medical Device and In Vitro Diagnostic Drug Approval Review and Safety Measures held by the Ministry of Health, Labour and Welfare on September 26, 2025. The Pharmaceutical Affairs Bureau Director explained the promotion of real-world data utilization through the amended Pharmaceuticals and Medical Devices Act and optimization of regulations through collaboration plans. The discussion emphasized advancing development of innovative medical devices using AI and other emerging technologies, particularly strengthening the implementation and review framework for Software as a Medical Device (SaMD). The PMDA President highlighted achieving review timeline targets and advancing scientific capability and internationalization.
