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									医疗器械审批中心发布《2019新型冠状病毒抗原/抗体检测试剂注册技术审评要点（试行）》								</h2>
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									<span>日期:2020-02-26</span>
								
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	<span style="margin:0px;padding:0px;max-width:100%;font-size:16px;box-sizing:border-box !important;overflow-wrap:break-word !important;"><strong>关于发布《2019新型冠状病毒抗原/抗体检测试剂注册技术审评要点（试行）》的通告</strong></span>
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	<span style="margin:0px;padding:0px;max-width:100%;font-size:16px;color:#888888;box-sizing:border-box !important;overflow-wrap:break-word !important;">（2020年第6号）</span><strong></strong>
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	<span style="margin:0px;padding:0px;max-width:100%;font-size:16px;box-sizing:border-box !important;overflow-wrap:break-word !important;">为应对新型冠状病毒肺炎疫情，按照“统一指挥、早期介入、随到随审、科学审批”的原则和确保产品安全、有效、质量可控的要求，我中心制定了《2019新型冠状病毒抗原/抗体检测试剂注册技术审评要点（试行）》，现予以发布。</span>
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	<span style="margin:0px;padding:0px;max-width:100%;font-size:16px;box-sizing:border-box !important;overflow-wrap:break-word !important;">  特此通告。</span>
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	<span style="margin:0px;padding:0px;max-width:100%;font-size:16px;box-sizing:border-box !important;overflow-wrap:break-word !important;">  附件：2019新型冠状病毒抗原/抗体检测试剂注册技术审评要点（试行）</span>
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	<span style="margin:0px;padding:0px;max-width:100%;font-size:16px;box-sizing:border-box !important;overflow-wrap:break-word !important;">2020年2月25日</span>
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