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盘点中、美、欧认证批准的新冠病毒检测产品

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发表于 2020-10-14 12:42:45 | 显示全部楼层 |阅读模式

                    

                    

                    
                    
                    <section data-role="paragraph" data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.png" /></p></p></section><section><section><span><strong></strong></span></section><p><span>医疗器械媒体报道先锋</span></p><p><span>分享专业医疗器械知识</span></p></section><section><section><section><span>关注</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section data-role="paragraph" data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><br  /></section><section data-tools="gulangu" data-id="97590"><section><section data-autoskip="1"><p><span>截至3月22日24时,国内新冠肺炎现存确诊病例5120例(湖北4700例),累计死亡病例3270例(湖北2517例),累计报告确诊病例81093例。截至北京时间3月22日12时,国外184个国家和地区现存确诊病例220183例,累计确诊256278例,累计死亡11278例。</span></p><p><br  /></p><p><span>一波未平一波又起,这场爆发于中国内地的新冠疫情以迅雷不及掩耳之势席卷全球,中国在经历疫情峰值后又面临全球大爆发之势,据昨日新增报告境外输入病例39例,累计报告境外输入确诊病例353例,国内在立足“早发现、早报告、早隔离、早治疗”重要防控手段的基础上也必须严防境外输入。大家都知道世卫组织助理总干事Bruce Aylward博士曾说,中国在新型冠状病毒肺炎的诊疗、救治和控制方面所做的努力和投入是欧洲无法企及的,如果自己患新冠肺炎,愿意到中国接受治疗,因为中国在这方面做得很成功。</span></p><p><br  /></p><p><p><img src="image/20201014/8716257ab0c86ef1f54d9247cacbf386_2.png" /></p></p><p><br  /></p><p><span>从物资到经验,中国政府已经宣布向82个国家和世卫组织、非盟提供援助,其中多批援助物资已经送达受援方。这是中国对危难关头曾向我们伸来援手的回报,更展现了构建人类命运共同体的中国担当。中国IVD行业在这场疫情中也承担着不可或缺的角色,新冠检测产品成为这次流行病中的一个骄子,越来越多的中国IVD企业产品获得国家药监局批准注册上市,越来越多的中国IVD企业产品进入欧盟为其缓解一线压力,越来越多的中国IVD企业产品进军FDA慷慨解囊。</span></p><p><br  /></p><p><span>这场持续的疫情,对中国而言,是机遇也是挑战,中国在这场疫情中所做的贡献,不亚于一个大国的担当,面对国际流言泛滥的宵小之辈,中国宽容则个;对于IVD行业而言,更是机遇和挑战,此次疫情,行业力量显而易见,进军国际有利于提升竞争力,但疫情阴霾终将散去,行业也要考虑未来之应对办法。尽管路途艰难,中国做到了,行业做到了,中国人民也做到了!</span></p><p><br  /></p><p><span>当然,中国百家IVD企业究竟能不能拯救国际疫情?诚如中国究竟能不能拯救世界疫情?中国和中国检测产品只是这场世界疫情中的关键一环,能救自己的,有时候只有自己。</span></p></section><section data-width="100%"><p><img src="image/20201014/c6b10992aa936707d91cd4b0cbc3df1b_3.gif" /></p></section></section></section><section data-tools="gulangu" data-id="14" data-color="#374aae"><section><section data-brushtype="text"><span>据CAIVD不完全统计,目前国内IVD企业产品获国家药监局批准注册25家,获欧盟CE认证或准入98家,获FDA PEUA 6家、FDA EUA 13家。</span></section></section></section><section data-role="paragraph"><p><br  /></p><p><p><img src="image/20201014/296a9892d6226cc44b7ad4460401cc22_4.png" /></p><br  /></p></section><p><p><img src="image/20201014/f64da97e626822db69e9b1da5dcdddf8_5.png" /></p></p><p><p><img src="image/20201014/2644968340e41b5336d5cfcb635a569e_6.png" /></p></p><p><p><img src="image/20201014/1db7c47a2a4ba7f52c94b3a0d593d4be_7.png" /></p></p><p><p><img src="image/20201014/9e63b984b072dbbb167f99f12ff2f3c3_8.png" /></p></p><p><p><img src="image/20201014/361068cd610e991649353fd2e427e2c8_9.png" /></p></p><p><p><img src="image/20201014/5d9a15644160a6130c96ddd799eb0000_10.png" /></p></p><p><p><img src="image/20201014/972a85d7a1a758f0beaadab7db92fff8_11.png" /></p></p><p><br  /></p></section></section></section></section></section></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="paragraph"><section><section><section 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