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【分享】免临床目录对比分析
本文根据NMPA发布了新的医疗器械免临床目录调整情况将新增的免临床产品单独汇总，将产品描述修订对免临床的范围有实质影响的产品也单独汇总，将更新内容进行对比。
【分享】免临床目录对比分析
【分享】射频美容设备注册审查要点
本文基于已发布的《射频美容设备注册审查指导原则》，为大家梳理重点，希望通过这篇文章，让大家能深入的了解射频美容产品的注册要点，合理安排产品上市计划。
【分享】射频美容设备注册审查要点
【CMDE】关于发布椎间融合器同品种临床评价注册审查指导原则的通告（2023年第20号）
器审中心发布椎间融合器同品种临床评价注册审查指导原则，适用于常规设计的椎间融合器同品种临床评价，该类产品分类编码为13-03-04，管理类别为III类。
【CMDE】关于发布椎间融合器同品种临床评价注册审查指导原则的通告（2023年第20号）
医疗器械临床评价路径分析
本文主要介绍了医疗器械临床评价路径决策的分析思路，以便企业更好的通过非临床试验的方式完成临床评价。
医疗器械临床评价路径分析
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联系UC
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