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【CMDE】关于发布人工智能辅助检测医疗器械（软件）临床评价注册审查指导原则的通告（2023年第38号）
人工智能辅助检测产品，分类编码为21-04-02，管理类别为第III类,是指基于计算机人工智能算法，可包含模式识别和数据分析等功能，通过识别、标记、突出等方式提示医师关注可能的异常/病变区域，从而辅助临床医师做出相应诊疗决策的产品，可为独立软件或嵌入式软件.
【CMDE】关于发布人工智能辅助检测医疗器械（软件）临床评价注册审查指导原则的通告（2023年第38号）
【会议通知】医疗器械&体外诊断试剂注册申报及临床评价技术研讨会
欢迎各企业参加由瑞旭集团-北京西尔思联合良渚生命科技小镇特于2023年10月20日举办的“医疗器械&体外诊断试剂注册申报及临床评价技术研讨会”。
【会议通知】医疗器械&体外诊断试剂注册申报及临床评价技术研讨会
【会议通知】医疗器械研发注册与GMP合规生产公益培训
欢迎各企业参加瑞旭集团-北京西尔思联合允咨医药培训中心于2023年8月18日在杭州开元萧山酒店（浙江省杭州市萧山区人民路77号）举办的“医疗器械研发注册与GMP合规生产公益培训”。
【会议通知】医疗器械研发注册与GMP合规生产公益培训
【会议通知】医疗器械产品医用软件国内注册研讨会
欢迎各企业参加瑞旭集团联合中检集团南方测试股份有限公司于2023年3月30日在苏州市举办的“医疗器械产品医用软件国内注册研讨会”。
【会议通知】医疗器械产品医用软件国内注册研讨会
眼底病变人工智能医疗软件临床试验现状
目前人工智能类医疗软件临床试验在中国许多地方开展，适应症广泛，获批的产品也在不断的增加，以眼底病变产品为例获批的产品就有：糖尿病视网膜病变辅助诊断类产品、慢性青光眼视神经眼底病变辅助诊断产品以及多病种（视网膜黄斑变性等产品）类。本文列举除目前视网膜病变方向人工智能医疗软件类主要开展的临床试验情况，供有需求企业参考。
眼底病变人工智能医疗软件临床试验现状
医疗器械网络安全能力详解及自评（四）
医疗器械网络安全能力详解及自评
医疗器械网络安全能力详解及自评（四）
医疗器械网络安全能力详解及自评（三）
医疗器械网络安全能力详解及自评
医疗器械网络安全能力详解及自评（三）
医疗器械网络安全能力详解及自评（二）
医疗器械网络安全能力详解及自评
医疗器械网络安全能力详解及自评（二）
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