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新闻资讯
【NMPA】国家药监局关于发布免于进行临床评价医疗器械目录的通告（2025年第19号）
国家药监局关于发布免于进行临床评价医疗器械目录的通告（2025年第19号）
【NMPA】国家药监局关于发布免于进行临床评价医疗器械目录的通告（2025年第19号）
【CMDE】关于征集参与《半月板缝合系统注册审查指导原则》等9项指导原则编制工作的相关企业及单位信息的通知
关于征集参与《半月板缝合系统注册审查指导原则》等9项指导原则编制工作的相关企业及单位信息的通知
【CMDE】关于征集参与《半月板缝合系统注册审查指导原则》等9项指导原则编制工作的相关企业及单位信息的通知
【CMDE】国家药监局器审中心关于发布移动医疗器械注册审查指导原则（2025年修订版）的通告（2025年第9号）
国家药监局器审中心关于发布移动医疗器械注册审查指导原则（2025年修订版）的通告（2025年第9号）
【CMDE】国家药监局器审中心关于发布移动医疗器械注册审查指导原则（2025年修订版）的通告（2025年第9号）
【NMPA】国家药监局关于发布医疗器械网络销售质量管理规范的公告（2025年第46号）
国家药监局关于发布医疗器械网络销售质量管理规范的公告（2025年第46号）
【NMPA】国家药监局关于发布医疗器械网络销售质量管理规范的公告（2025年第46号）
【NIFDC】2025年第一次医疗器械产品分类界定结果汇总
2025年第一次医疗器械产品分类界定结果汇总
【NIFDC】2025年第一次医疗器械产品分类界定结果汇总
[CMDE]国家药监局器审中心关于发布体外膜肺氧合系统临床评价注册审查指导原则的通告（2025年第8号）
为进一步规范体外膜肺氧合系统的管理，国家药监局器审中心组织制定了《体外膜肺氧合系统临床评价注册审查指导原则》，现予发布。
[CMDE]国家药监局器审中心关于发布体外膜肺氧合系统临床评价注册审查指导原则的通告（2025年第8号）
【收藏】关节手术导航系统的CER+案例分享
关节手术导航系统的CER+案例分享
【收藏】关节手术导航系统的CER+案例分享
【CMDE】关于征集《腔镜用吻合器产品注册技术审查指导原则（2025年修订版）》等两项指导原则修订工作参与企业及单位信息的通知
关于征集《腔镜用吻合器产品注册技术审查指导原则（2025年修订版）》等两项指导原则修订工作参与企业及单位信息的通知
【CMDE】关于征集《腔镜用吻合器产品注册技术审查指导原则（2025年修订版）》等两项指导原则修订工作参与企业及单位信息的通知
【CMDE】器审中心关于发布医疗器械技术审评中心创新医疗器械特别审查申请审查实施细则等2项实施细则的通告（2025年第7号）
器审中心制定了《医疗器械技术审评中心创新医疗器械特别审查申请审查实施细则》《医疗器械技术审评中心医疗器械优先审批申请审核实施细则》，现予发布。
【CMDE】器审中心关于发布医疗器械技术审评中心创新医疗器械特别审查申请审查实施细则等2项实施细则的通告（2025年第7号）
【收藏】CER+在临床评价中的应用
CER+在临床评价中的应用
【收藏】CER+在临床评价中的应用
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