刚刚！药监局公布第一批实施唯一标识产品清单！

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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.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 powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><span><br  /></span></section><section><span><span>刚刚，药监局发布《国家药监局综合司公开征求&lt;关于做好第一批实施医疗器械唯一标识工作有关事项的通告（征求意见稿）&gt;意见》，</span><span><strong>包括第一批产品试用清单和具体工作安排，</strong></span><span>准备注册或者延续注册的朋友们要注意啦：</span></span><span></span></section></section></section></section></section></section><section powered-by="gulangu"><p><br  /></p><p><p><img src="image/20201014/5b74df8afcc86f2f2a7827e332cae413_2.png" /></p></p><section><br  /></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><p><span><strong>品种范围</strong></span><span><strong></strong></span></p><p><br  /></p></section></section></section><section powered-by="gulangu"><section><span>按照风险程度和监管需要，确定部分有源植入类、无源植入类等高风险第三类医疗器械作为第一批医疗器械唯一标识实施品种，具体产品目录见下图：</span><span></span></section><p><br  /></p><p><p><img src="image/20201014/f3ef24a86b4edc1b610864a2442a8df0_3.png" /></p></p><p><span></span></p><p><p><img src="image/20201014/14ed6b5c686a8c1c9b42db93ccc3418d_4.png" /></p></p><p><p><img src="image/20201014/3d72ff448ea655c19e5c7ca7f36c7f6d_5.png" /></p></p><p><p><img src="image/20201014/6da6ff260337290e055282f573d46865_6.png" /></p></p><p><p><img src="image/20201014/4dc924fdf4fca1bcf292e8dfaae67103_7.png" /></p></p><p><p><img src="image/20201014/716141e20ea16ec3ae8bd0149c48dce1_8.png" /></p></p><p><p><img src="image/20201014/9e762e57661b390415715f79d9f49e45_9.png" /></p></p><p><p><img src="image/20201014/e3e79fd4b6e559690093be1453b3e18c_10.png" /></p></p><p><p><img src="image/20201014/96e4e521875491662d3a17fabaf6ca8f_11.png" /></p></p><p><p><img src="image/20201014/3970ec24773ccf3c70b080ccb9119415_12.png" /></p></p></section><section powered-by="gulangu"><section><section powered-by="gulangu"><br  /></section></section><section><section powered-by="gulangu"><section><span><strong>进度安排</strong></span></section><section></section></section></section></section><section powered-by="gulangu"><section><span>对列入第一批实施产品目录的医疗器械，注册人应当按照时限要求有序开展以下工作：</span></section><p><br  /></p><section><span><strong><span>（一）唯一标识赋码</span></strong><strong><span></span></strong></span></section><section></section><section><span><strong><span>2020年8月1日起，生产的医疗器械应当具有医疗器械唯一标识</span></strong><span>；</span></span></section><p><br  /></p><section><span>2020年8月1日前已生产的医疗器械可不具有医疗器械唯一标识。生产日期以医疗器械标签为准。</span></section><p><br  /></p><section><span><strong><span>（二）唯一标识注册系统提交</span></strong><strong><span></span></strong></span></section><section><br  /></section><section><span><span><strong>2020年8月1日起，申请首次注册的，注册申请人应当在注册管理系统中</strong></span><strong><span>提交其最小销售单元的产品标识</span></strong><span><strong>；</strong><strong></strong></span></span></section><p><br  /></p><section><span>2020年8月1日前，已受理或者获准注册的，注册人应当在产品延续注册或者注册变更时，在注册管理系统中提交其最小销售单元的产品标识。</span></section><p><br  /></p><section><span><strong>产品标识不属于注册审查事项，产品标识的单独变化不属于注册变更范畴。</strong><strong></strong></span></section><p><br  /></p><section><span><strong><span>（三）唯一标识数据库提交</span></strong><strong><span></span></strong></span></section><section></section><section><span><span><strong>2020年8月1日</strong></span><span><strong>起生产的医疗器械，在其上市销售前，注册人应当按照相关标准或者规范要求将最小销售单元、更高级别包装的产品标识和相关数据上传至医疗器械唯一标识数据库；</strong><strong></strong></span></span></section><p><br  /></p><section><span>当医疗器械产品最小销售单元产品标识的相关数据发生变化时，注册人应当在该产品上市销售前，在医疗器械唯一标识数据库中提交变更申请，审核通过后实现数据更新。医疗器械最小销售单元产品标识变化时，应当按照新增产品标识上传数据至医疗器械唯一标识数据库。</span><span></span></section><section><span><br  /></span></section></section><section powered-by="gulangu"><section><section powered-by="gulangu"><section>&nbsp; &nbsp;<span><strong>工作要求</strong></span></section><p><br  /></p></section></section></section><section powered-by="gulangu"><p><span>（一）强化企业责任。第一批实施唯一标识工作的注册人应当高度重视，充分认识《规则》实行的重要意义，严格按照《规则》和本通告要求组织开展赋码、数据上传和维护等工作，并对数据真实性、准确性、完整性负责。</span></p><p><br  /></p><p><span>（二）调动各方积极性。鼓励注册人应用医疗器械唯一标识建立医疗器械信息化追溯系统，实现对其产品生产、流通、使用全程可追溯。鼓励医疗器械生产经营企业、使用单位在其相关管理活动中积极应用医疗器械唯一标识，探索建立与上下游的追溯链条，推动衔接应用。</span></p><p><br  /></p><p><span>（三）加强培训宣传。积极开展《规则》培训工作，对注册人、生产经营企业、使用单位等开展有针对性的业务培训，组织有关人员认真学习，加强工作指导，保障政策有效实施。加大新闻宣传力度，正确引导，形成良好的舆论氛围。</span><span></span></p></section><p><br  /></p><p><span>来源:国家药品监督管理局</span></p><p><span>整理：</span><span>Eshare医械汇</span><span></span></p><p><br  /></p><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph"><section><a data-miniprogram-appid="wxdc7efe409d688f37" data-miniprogram-path="pages/authorizationLogin/authorizationLogin" data-miniprogram-nickname="" href="" data-miniprogram-type="image" data-miniprogram-servicetype="" href=""><p><img src="image/20201014/2e25c809fffd6ef0866d70b58effc1a6_13.gif" /></p></a><br  /></section><section><br  /></section><section powered-by="gulangu"><section powered-by="gulangu"><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph"><section><section><section data-brushtype="text"><strong>相关阅读</strong></section></section></section><section><section></section></section><section data-width="100%"><section><section><section><section data-width="100%"><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><section><p><img src="image/20201014/2aac877ff9233ba5a66e7a5ff3a4febf_14.gif" /></p></section><section data-brushtype="text">戳一下，更有料！</section></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><section data-brushtype="text"><span>献礼新中国成立70周年——国产首台全数字便携彩超篇</span></section></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><section data-brushtype="text"><br  /></section></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><span>献礼新中国70周年——李果珍教授与首台CT进入中国！</span><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><br  /></section><section data-tools="gulangu" data-id="87578" data-color="#6aa9ad" data-custom="#59c3f9"><span>献礼新中国70周年——纪念中国首台磁共振诞生</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></section></section></section></section></section></section><p><br  /></p><p><p><img src="image/20201014/cd6e6da350853c459044672a7cf353fb_15.jpg" /></p></p>