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      <title>重磅上市｜全国首张膀胱癌FISH三类证，无创早筛新标杆</title>
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      <description><![CDATA[恭喜！强强联手]]></description>
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      <title>先声医疗人类多基因突变测序试剂盒，进入优先审批通道!</title>
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      <description><![CDATA[恭喜先声医疗！]]></description>
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      <author>药监局器审中心</author>
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      <title>国内首张欧盟CE-IVDR核酸类居家自测证书正式获批</title>
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      <pubDate>Mon, 20 Apr 2026 07:59:28 +0000</pubDate>
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      <title>领航基因三类IVD新品审评报告公开</title>
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      <description><![CDATA[《金黄色葡萄球菌、念珠菌、肠球菌、链球菌核酸检测试剂盒（数字 PCR 法）》产品注册技术审评报告]]></description>
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      <title>【关注】近十年中国医疗器械注册工作进展与发展趋势</title>
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      <description><![CDATA[法规体系从“零散修订”到“系统构建”，监管模式从“事后监管”到“全生命周期监管”，标准体系从“跟跑国际”到“参与主导”，注册数量从“稳步增长”到“量质齐升”，创新产品从“零星突破”到“全面开花”，为我 ... ...]]></description>
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      <author>致众医疗器械资讯</author>
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      <pubDate>Thu, 26 Mar 2026 08:01:02 +0000</pubDate>
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      <link>https://www.iivd.net/article-44297-1.html</link>
      <description><![CDATA[艾德生物PIK3CA检测试剂盒覆盖了甲磺酸瑞索利塞片药效相关的10个检测位点，具有检测结果准确、检测成功率高、性能稳定性好、样本需求量少及报告出具速度快等特点，是 OCCC 患者诊断的重要产品。 ... ...]]></description>
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      <pubDate>Tue, 24 Mar 2026 03:24:55 +0000</pubDate>
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      <title>2026年2月，迈瑞、圣湘、迈克等38款IVD新品获批上市！</title>
      <link>https://www.iivd.net/article-44213-1.html</link>
      <description><![CDATA[关注小桔灯网]]></description>
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      <author>国家药监局</author>
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      <pubDate>Wed, 18 Mar 2026 06:42:40 +0000</pubDate>
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      <author>迈瑞</author>
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      <link>https://www.iivd.net/article-43938-1.html</link>
      <description><![CDATA[在资源受限或基层医院场景，免疫层析的可及性具有现实优势。]]></description>
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      <author>IVD工具人</author>
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      <pubDate>Fri, 27 Feb 2026 03:07:26 +0000</pubDate>
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      <title>47款IVD产品获批！（2026年1月）（2026年第20号）</title>
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      <pubDate>Thu, 26 Feb 2026 02:44:00 +0000</pubDate>
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      <link>https://www.iivd.net/article-43874-1.html</link>
      <description><![CDATA[全球技术同步、本土智造赋能]]></description>
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      <author>生物梅里埃</author>
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      <pubDate>Tue, 10 Feb 2026 02:13:04 +0000</pubDate>
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      <title>中国miRNA检测试剂盒获证（III类）企业梳理（截至26年1月）</title>
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      <author>令狐冲说PCR</author>
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      <pubDate>Tue, 03 Feb 2026 02:35:20 +0000</pubDate>
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      <link>https://www.iivd.net/article-43811-1.html</link>
      <description><![CDATA[三类注册证]]></description>
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      <author>优咨康</author>
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      <link>https://www.iivd.net/article-43755-1.html</link>
      <description><![CDATA[临床前性能验证严谨、大规模临床试验数据]]></description>
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      <pubDate>Mon, 26 Jan 2026 02:46:08 +0000</pubDate>
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      <pubDate>Sat, 24 Jan 2026 12:35:53 +0000</pubDate>
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      <description><![CDATA[用户需求是风险管理的“源头输入”，需在全流程中保持一致性]]></description>
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      <pubDate>Thu, 22 Jan 2026 02:55:30 +0000</pubDate>
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      <description><![CDATA[恭喜燃石医学]]></description>
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