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 presents the minutes of the 20th regular opinion exchange meeting held on September 1, 2022, regarding the approval review and safety measures of medical devices and in vitro diagnostic drugs. Hosted by Japan's Ministry of Health, Labour and Welfare, the meeting was conducted online. Director-General Yashiro thanked medical device manufacturers for their cooperation in COVID-19 response and discussed rapid review processes, OTC approval of antigen test kits, and new systems established through the 2019 amendments to the Pharmaceutical Affairs Law. The ministry also explained its review of update approval simplification for software-based medical devices, with industry stakeholder engagement emphasized.
