第１９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１９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 19th Regular Consultation Meeting on Medical Device and In Vitro Diagnostic Approval Reviews and Safety Measures held on August 27, 2021. The Ministry of Health, Labour and Welfare and industry representatives discussed stable supply and expedited reviews of medical devices and diagnostics during COVID-19 response. Officials outlined improvements to the pharmaceutical regulatory framework established by the 2019 Pharmaceuticals and Medical Devices Act amendments, enhanced support for software as a medical device (SaMD), and PMD agency restructuring to strengthen industry collaboration.
