Core Insights - The National Medical Products Administration has included Suzhou Yunhejing New Material Technology Co., Ltd.'s "Surface Porous Polyether Ether Ketone Interbody Fusion Device" in the special review list for innovative medical devices, marking a significant achievement for the company and the Taicang region [1] - Taicang's medical device industry has shown rapid growth, with nearly 100 production enterprises and a total of around 300 Class II and III medical device registration certificates obtained, along with over 500 Class I medical device filings [2] - The establishment of a global procurement and supply chain center by PerkinElmer in Taicang is expected to inject new momentum into the high-quality development of the local medical device industry [2] Company Developments - Suzhou Yunhejing's interbody fusion device utilizes patented technology to create a PEEK device with a connected porous structure, addressing clinical challenges related to traditional PEEK devices [1] - Zhuoran Medical Technology's biological hernia repair patch has achieved breakthroughs in key technologies, filling several domestic and international technical gaps [1] Industry Support Mechanisms - The introduction of a "special class docking + customized service" mechanism aims to provide tailored support for enterprises, with over 70 services conducted in the biopharmaceutical industry this year [4] - Active collaboration with provincial review and inspection experts has facilitated targeted guidance for enterprises, addressing critical technical issues in the registration process [6] - The Taicang Market Supervision Bureau is committed to enhancing the efficiency of the Jiangsu Provincial Drug Administration's review and inspection work station, promoting the rapid transformation and application of innovative biopharmaceutical achievements [8]

报名：首届全球眼科大会 | 议程更新 报名：首届全球心血管大会 | 奖项申报 报名：首届全球骨科大会 | 奖项评选 合作伙伴征集：2025全球手术机器人大会 2025年3月26日，NMPA公布了创新医疗器械特别审查申请审查结果公示（2025年第3号），有14款产品进入创新通道。 | | 公众号 邮箱登录 内部培训系统 使用指南 网站地图 | | | --- | --- | --- | | mnr 国家药品监督管理局医疗器械技术审评中心 Center For Medical Device Evaluation . NMPA | 请输入关键字 Q | | | G 机构概况 信息公开 法规文件 | 审评科学 办事大厅 | | | 创新医疗器械特别审查申请审查结果公示（2025年第3号） | | | | | | 发布时间:2025-03-26 | 1. 产品名称：人类3号和10号染色体异常细胞检测试剂盒（荧光原位杂交法） 公司已获得两项国家创新医疗器械审批，先后被评为国家高新技术企业、江苏省潜在独角兽企业、江苏省双创人才企业等，申请、授权国家发明专利 36 项、国际 专利 5 项。 申请人：珠海圣美生物诊断技术有限公 ...