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01有源手术器械
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【CMDE】关于公开征求《软性内窥镜用高频手术器械注册审查指导原则（征求意见稿）》意见的通知
该指导原则适用于分类编码为01-03-04的产品与高频手术设备配合使用，通过软性内窥镜的器械通道进入人体，利用高频电流对人体组织实施切开、凝血、活检、切除等操作。
【CMDE】关于公开征求《软性内窥镜用高频手术器械注册审查指导原则（征求意见稿）》意见的通知
【会议通知】有源医疗器械注册及临床技术公益培训
欢迎参加2023年11月10日《医疗装备》杂志社联合瑞旭集团-北京西尔思科技有限公司，在线举办的“有源医疗器械注册及临床技术公益培训”。
【会议通知】有源医疗器械注册及临床技术公益培训
【会议通知】有源医疗器械注册临床技术研讨会【11月10日线上会议】
欢迎参加北京《医疗装备》杂志社联合瑞旭集团-北京西尔思于2023年11月10日举办的“有源医疗器械注册临床技术研讨会”线上会议。
【会议通知】有源医疗器械注册临床技术研讨会【11月10日线上会议】
【会议通知】医用美容仪产品合规技术研讨会
欢迎各企业参加瑞旭集团-北京西尔思联合杭州希科检测于2023年7月28日在上海市黄浦区南京西路338号仙乐斯广场2楼荟立方图兰朵厅举办的“医用美容仪产品合规技术研讨会”。
【会议通知】医用美容仪产品合规技术研讨会
【分享】超声医美产品注册要点
聚焦超声医美技术是一种非侵入性的美容方法，通过利用超声波的能量对皮肤进行治疗和修复。超声医美产品在我国作为第三类医疗器械管理，
【分享】超声医美产品注册要点
【CMDE】国家药监局器审中心关于发布腹腔内窥镜手术系统技术审评要点（2023年修订版）的通告（2023年第18号）
器审中心发布腹腔内窥镜手术系统技术审评要点，该产品分类编码为01-07-03，管理类别为Ⅲ类。
【CMDE】国家药监局器审中心关于发布腹腔内窥镜手术系统技术审评要点（2023年修订版）的通告（2023年第18号）
【CMDE】国家药监局器审中心关于发布超声软组织手术设备注册审查指导原则（2023年修订版）的通告（2023年第4号）
本指导原则为《医疗器械分类目录》中子目录为01有源手术器械，分类编码为01-01-01的指导原则，有需求企业可在原文中直接下载。
【CMDE】国家药监局器审中心关于发布超声软组织手术设备注册审查指导原则（2023年修订版）的通告（2023年第4号）
关于公开征求《腹腔内窥镜手术系统技术审查指导原则 第1部分：手术器械（征求意见稿）》意见的通知
本指导原则为《腹腔内窥镜手术系统技术审查指导原则》的第一部分：手术器械。
关于公开征求《腹腔内窥镜手术系统技术审查指导原则 第1部分：手术器械（征求意见稿）》意见的通知
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