Saved content diff

Before

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.

After

This page contains the proceedings of the 23rd Regular Opinion Exchange Meeting on Medical Device and In Vitro Diagnostic Approval Reviews and Safety Measures, held on September 26, 2025. Hosted by the Pharmaceutical Affairs Bureau of the Ministry of Health, Labour and Welfare, the meeting was conducted in a hybrid format at PMDA conference rooms and online. Director Miyamoto reported the May enactment of the revised Pharmaceutical Affairs Law, clarifying real-world data utilization in pharmaceutical applications and promoting AI-driven medical device development. PMDA President Fujiwara emphasized achieving review timeline targets and advancing the fifth mid-term plan focusing on scientific capability enhancement, internationalization, and operational efficiency improvement.