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<section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><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"><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>医疗器械第一新媒体</span></p><p><span>分享专业医疗器械知识</span></p></section><section><section><section>关注</section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><p><strong><span>来源：搜集整理自网络</span></strong></p><p><strong><span><br /></span></strong></p><p><p><img src="image/20201014/e6d9ca69a1825656c1da932819797faf_2.jpg" /></p></p><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section></section><section></section><section><section><p><strong>什么是UDI</strong></p></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><p>UDI的全称是Unique Device Identification，即“唯一器械标识”。UDI是对医疗器械在其整个生命周期赋予的身份标识，是其在产品供应链中的唯一“身份证”。</p><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/7b070babe8c5d2fab3ef6b83075c1453_3.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p><span>（UDI代码结构）</span><br /></p></section></section></section><section powered-by="gulangu"><section><section><p><br /></p><p>以ICCBBA颁发的UDI形式举例：</p><p><br /></p><p><p><img src="image/20201014/e2fb238710449eea1a509d93c284eae1_4.png" /></p></p><p>在上表所示的例子中，“=/”后面的符号代表器械识别码，“=，”后面的符号代表序列号，“=”后面的符号代表地方识别码，“=>”后面的数字代表了过期时间，“=）”后面的数字代表生产时间，最后“&，1”后面的符号代表MPHO 批号。</p><p>需要注意的是，ICCBBA关于血袋的UDI形式有区别于一般医疗器械。</p><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/078d90d1e6c2664b810fc5f6b72b5e92_5.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p><span>（UDI编制方法）</span><br /></p></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/ee630c18cebca767469679bdb3e041a9_6.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p><span>（UDI数据载体）</span><br /></p></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section></section><section></section><section><section><p><strong>UDI的适用范围</strong></p></section></section></section></section></section><section powered-by="gulangu"><section><section><p>众所周知，UDI是美国食品药物管理局FDA建立的”特殊医疗器械的识别系统”。你可能会疑惑UDI的适用范围是什么呢？<span>答案是“全球”！</span></p><p><span><br /></span></p><p><span>国际医疗器械监管机构论坛（IMDRF，原名GHTF）在2011年完成了对UDI实施原则的协调，提出了《医疗器械UDI系统》指导性最终文件，推动UDI作为全球医疗器械上市后追溯的基本手段，并推荐UDI采用开放的GS1国际物品编码标准。欧洲医疗器械行业协会（Eucomed）在此框架下进一步制定了《基于风险管理的不同包装级别医疗器械UDI标识要求》。美国等先进国家也积极制定UDI政策法规，推动UDI在本国的规范管理与应用实施。</span></p><p><span><br /></span></p><p>而中国于1991年4月由中国物品编码中心代表，加入国际物品编码协会（GS1），负责推广国际通用的、开放的、跨行业的全球统一编码标识系统和供应链管理标准，向社会提供公共服务平台和标准化解决方案。</p></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section></section><section></section><section><section><p><strong>UDI的作用</strong></p></section></section></section></section></section><section powered-by="gulangu"><section><section><p>各大医疗器械体系在推广UDI的介绍词中都包括了<strong><span>安全性，可追踪性，高效性。</span></strong><span>这是因为UDI可以迅速并明确地识别出器械安全和有效性的关键属性。</span></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/9c3a662d9c5c371eb5024a6b44d9a1d9_7.png" /></p></section></section><section><section></section></section><section>FDA法规对于各类医疗器械的符合日期进行规定：</section><section>以下列出了实施UDI最终法规的重要日期及关键合规要求。注意：对于在合规日期前已贴标的库存成品器械，设有三年特例免除的规定。</section><section><br /></section><p><p><img src="image/20201014/f79a800b93d3b274f59ce410e58d538e_8.png" /></p></p><p><p><img src="image/20201014/c355a0767c971a1114120746b4e26fef_9.png" /></p></p><section><strong><span>美国FDA已经于2016年9月24日对II类和III类医疗器械要求必须实施UDI码！</span></strong></section><section>器械标签上的日期的格式，必须符合21 CFR 801.18的规定，并且器械的数据均必须提交至GUDID数据库。</section><section><br /></section></section><section powered-by="gulangu"><section><section><p><span></span><span>全球采用统一的、标准的UDI有利于提高供应链透明度和运作效率；有利于降低运营成本；有利于实现信息共享与交换；有利于不良事件的监控和问题产品召回，提高医疗服务质量，保障患者安全。</span></p></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/6111eabbf4db0282b474406e7eeb6975_10.png" /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>中国物品编码中心</strong></p><p>是统一组织、协调、管理我国商品条码、物品编码与自动识别技术的专门机构，隶属于国家质量监督检验检疫总局，1988年成立。中国物品编码中心在全国设有46个分支机构，形成了覆盖全国的集编码管理、技术研发、标准制定、应用推广以及技术服务为一体的工作体系。物品编码与自动识别技术已广泛应用于零 售、制造、物流、电子商务、移动商务、电子政务、医疗保健、产品质量追溯、图书音像等国民 经济和社会发展的诸多领域。</p></section></section></section></section></section></section></section><p><br /></p></section></section></section></section><p><span>（本文搜集整理自网络）</span></p><p><span><br /></span></p><p>查一查：下图所示设备的UDI是什么？怎么根据UDI码查询呢？复制以下网址到浏览器https://accessgudid.nlm.nih.gov/ 或是点击阅读原文即可查询哦~快动动手查询一下你手边或是你感兴趣的医疗器械的UDI码吧！如果你查询出来的英文结果和医疗器械的中文标示不符，欢迎截图在下面留言哦~小编有奖励！</p><p><br /></p><p><p><img src="image/20201014/c4ab4758abd296fea84dd9cfdd703448_11.jpg" /></p></p><p><br /></p><p><p><img src="image/20201014/938cf0b0b1666dac16571ed852c72ba9_12.jpg" /></p></p><p><br /></p><p>小编动手查了一下，结果如下呢：</p><p><br /></p><p><p><img src="image/20201014/9571045290567b233bf72bc0195e6713_13.jpg" /></p></p><p><strong><span><br /></span></strong></p><p><strong><span><p><img src="image/20201014/136b953773c607f1be62c7b002beb7ef_14.jpg" /></p></span></strong></p><p><strong><span>本文由原创/整理自网络，转载请注明出处。</span></strong></p><section data-id="1658"><section><section><section data-id="1658"><section><section><section data-id="1658"><section><section><section data-id="1658"><section><section><p><span><strong>相关阅读</strong></span></p></section><p><p><img src="image/20201014/ec237188ae1e9c03eb4d9814f31b18ab_15.gif" /></p></p><p><span>【从业必读】一械一码，唯一器械标识(UDI)为何“落地”难？</span><br /></p><p><br /></p><p><span>医疗器械全国统一编码浮出水面</span><br /></p><p><br /></p><p><span>首届进博会“战报”：成交578.3亿美元！医疗产品57.6亿美元！</span><br /></p><p><br /><span>4484亿！中国超过日本跃居全球第二大医疗器械市场！</span></p></section></section></section></section></section></section></section></section></section></section></section><p><br /></p><p><p><img src="image/20201014/225eae26a91575de7508aebe3e999278_16.jpg" /></p></p><p><strong><span><br /></span></strong></p><p><strong><span>点击阅读原文即可查询！如果你查询出来的结果和医疗器械的中文标示不符，欢迎截图在下面留言哦~小编有奖励！</span></strong></p>
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发表于 2020-10-14 15:18:12