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<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.jpg" /></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><span></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-tools="gulangu" data-id="97917"><section><section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><p><br /></p><p mpa-paragraph-type="body"><span>继此前对中国口罩企业的过滤效果发难后对中国口罩企业此前FDA注册的某些不合规成了美方新的清算方向。<br /></span></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><span>刚刚，美国开始抛出第二个清算利器：中国口罩企业提供虚假的FDA注册信息！</span></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="image"><p><img src="image/20201014/1d6f4d347d822829465716d6b38816c8_2.jpg" /></p></p><p mpa-paragraph-type="image"><br /></p><p mpa-paragraph-type="body"><span>华尔街日报(WSJ)一份分析显示，超过1,300家中国医疗器材公司，在2019年冠状病毒疾病(COVID-19)肆虐期间，据称将德拉瓦州(Delaware)一个实体列为其在美国的代表，但该实体使用的，却是假地址和无人接听的电话号码。</span></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><span>华尔街日报报导，所有外国医疗器材制造商都被要求在美国必须有一个代理机构或称代表处，此代表处必须拥有真实地址，且在营业时间有人值班接听电话。</span></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><span>这些公司的美国代表，是食品暨药物管理局(FDA)与这些海外公司之间的联络人，以便协调检查、召回或应付其他紧急需求。</span></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><span>华尔街日报的最新报道披露，仅仅从其调查的一家公司名为CCTC Service Inc的情况显示：至少1,300家注册的中国公司，将CCTC Service Inc.列为他们的美国代表。但根据公司纪录资料库，这家以CCTC Service Inc为名的公司在美国并不存在。</span></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><span>CCTC声称所在地址，是位于德拉瓦州威明顿(Wilmington)的一栋3房砖造房屋，该地址的房客和房东说，他们对CCTC或任何中国公司一无所知。</span></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><span>华尔街日报指出，CCTC的详细注册讯息源自一家名为Shenzhen CCT Testing Technology Co.的检测企业。</span></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><span>这家总部位于深圳的公司指出，它就是将CCTC列为那么多中国公司在美国代理人的幕后推手。</span></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><span>来自这家检测公司的资深经理Tony Mo在提到CCTC的时候说：“我们当然不是假的公司”。</span></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><span>但他也承认，这家被列在FDA众多纪录中的CCTC，从未正式在美国成立。</span></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="image"><p><img src="image/20201014/715d60aecc4e54e17f9860449fb7529f_3.png" /></p></p><p mpa-paragraph-type="image"><br /></p><p mpa-paragraph-type="body"><span>在FDA匆忙应对疫情大流行过程中，FDA的紧急使用授权计划出现监管漏洞。华尔街日报的调查结果，凸显FDA医疗器材资料库的瑕疵，防护口罩的销售商通常会援引FDA医疗器材资料库证明自身的合法性。</span></p><p mpa-paragraph-type="body"><span><br /></span></p><p mpa-paragraph-type="body"><span>FDA拒绝就CCTC置评。一名发言人表示，FDA的注册资料库对大众来说是一项有用工具，但列入该资料库不代表获得FDA批准，该机构也未认证资料库中的注册资讯。</span></p><p mpa-paragraph-type="body"><br /></p><p mpa-paragraph-type="body" data-mpa-powered-by="gulangu"><span>来自：海运电商在线</span></p><p><br /></p></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 data-brushtype="text"><strong>相关阅读</strong></section></section></section><section><section><br /></section></section><section 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发表于 2020-10-14 12:00:35