醫療器材

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EP238-醫療器材合規 vs 持續改善，FDA的自願計畫MDDAP是什麼?

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MDDAP（Medical Device Discovery Appraisal Program）是 US FDA 在2023年9月正式公佈的自願改進計劃（Voluntary Improvement Program, VIP）。核心與傳統的監管模式不同，從單純的「法規合規（Compliance）」轉向「持續改善(Continuous Improvement)」