第２０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２０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 20th Regular Opinion Exchange Meeting on Medical Device and In Vitro Diagnostic Drug Approval Reviews and Safety Measures, held on September 1, 2022. The meeting was hosted by the Ministry of Health, Labour and Welfare's Pharmaceutical and Medical Device Bureau via web. Director-General Yashiro praised medical device manufacturers' contributions during COVID-19 response, explaining expedited review of in vitro diagnostic drugs and OTC approval for antigen test kits. Discussions covered the Pharmaceutical Affairs Law amendments, including the pioneering medical device designation system, emergency approval system, and simplified review procedures for programmed medical devices. The ministry emphasized cooperation with industry to deliver improved medical devices to patients more rapidly.
