第２１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

This page presents the proceedings of the 21st Regular Opinion Exchange Meeting on Medical Device and In Vitro Diagnostic Drug Approval Review and Safety Measures, held on September 14, 2023. The Pharmaceutical Affairs Bureau Director noted that four years have passed since the 2019 Pharmaceutical Affairs Law amendment. The Ministry plans to review and update regulations while continuing collaborative optimization plans with industry. The introduction of the "Program Medical Device Practical Implementation Promotion Package Strategy 2" aims to accelerate AI-based medical device development. PMDA reported achieving all target review periods for medical devices and in vitro diagnostic products, emphasizing continued commitment to transparent and fair approval processes.