第１８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

This page contains the minutes of the 18th regular opinion exchange meeting on approval reviews and safety measures for medical devices and in vitro diagnostic drugs, held on August 28, 2020. Hosted via web due to COVID-19, the Ministry of Health, Labour and Welfare's Pharmaceutical and Medical Device Agency conducted discussions with the medical device industry. Director General Kamada thanked stakeholders for supporting pharmaceutical law amendments and reported accelerated approvals: 12 medical device certifications and 14 in vitro diagnostic drug approvals. The meeting emphasized promoting next-generation medical devices including AI-based programs, digital therapeutics, and next-generation genomic diagnostics, while strengthening cross-industry and government collaboration.