2019年10月NMPA「首次注册」184个产品数据分析

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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><p><br  /></p><section><span>2019年10月，国家药品监督管理局（NMPA）共批准首次注册医疗器械产品</span><span>43个</span><span>。</span><span>其中，境内第三类医疗器械产品</span><span>31个</span><span>，进口第三类医疗器械产品</span><span>9个</span><span>，进口第二类医疗器械产品</span><span>3个</span><span>。</span><br  /></section><section><p><img src="image/20201014/60632aed1cace098ea97b81847157c30_2.png" /></p></section><section><span>图：</span><span>2019年10月批准首次注册医疗器械产品的类别（来源：</span><a data-miniprogram-appid="wxfa5b20c93499db27" data-miniprogram-path="pages/yixiecha/index/index" data-miniprogram-nickname="医疗器械速查" href="" data-miniprogram-type="text" data-miniprogram-servicetype="" href=""><span>智械洞察</span></a><span>）</span></section><section><span><br  /></span></section><section><span>本月首次注册医疗器械产品数量相比上月（184个）大幅减少，相比2018年10月（86个）也减少了一半，同样远低于2018年的月平均值（100个）。</span></section><section><p><img src="image/20201014/6c7371cf7a1b7848c41c164712822020_3.png" /></p></section><section><p><img src="image/20201014/1aa169a048c5639c3cc19010689fcd5a_4.png" /></p></section><section><span>图：</span><span>2019年1~10月批准首次注册不同类型医疗器械产品的数量（来源：</span><span>智械洞察）</span></section><section><span><br  /></span></section><section>2018年1月至今，每个月NMPA批准首次注册的产品数量如下表所示。<br  /></section><section><br  /></section><section><p><img src="image/20201014/999dd335592428b4ddfe458610eb3feb_5.png" /></p></section><section><span>图：</span><span>2018年1月~2019年10月历月批准首次注册医疗器械产品的数量（来源：</span><a data-miniprogram-appid="wxfa5b20c93499db27" data-miniprogram-path="pages/yixiecha/index/index" data-miniprogram-nickname="医疗器械速查" href="" data-miniprogram-type="text" data-miniprogram-servicetype="" href=""><span>智械洞察</span></a><span>）</span></section><section><p><img src="image/20201014/3b44de0b8831324ab7eacdd6a4401124_6.png" /></p></section><section><strong><span>1）结构特征</span></strong></section><section><span><br  /></span></section><section><span>按照注册产品的结构特征区分，所有43款产品中，有源医疗器械14个，占全部注册数量的</span><span>32.6%</span><span>；</span><span>无源医疗器械4个，占全部注册数量的</span><span>9.3%</span><span>；</span><span>体外诊断试剂25个，占全部注册数量的</span><span>58.1%</span><span>。</span></section><section><span><br  /></span></section><section><p><img src="image/20201014/91ddcbc14065da09f3ef46ceeee06fc2_7.png" /></p></section><section><span>图：</span><span>2019年1~10月批准首次注册医疗器械产品的结构特征（来源：</span><a data-miniprogram-appid="wxfa5b20c93499db27" data-miniprogram-path="pages/yixiecha/index/index" data-miniprogram-nickname="医疗器械速查" href="" data-miniprogram-type="text" data-miniprogram-servicetype="" href=""><span>智械洞察</span></a><span>）</span></section><section><br  /></section><section><strong><span>2）分类目录</span></strong></section><section><span><br  /></span></section><section><span>按照产品所属医疗器械分类目录进行划分，除体外诊断试剂（25个）外，仅涉及新版《医疗器械分类目录》中的12个子目录。</span><span>注册品种数量排在前列的子目录分别是：</span><span>有源手术器械（4个）、医用成像器械（3个）以及神经和心血管手术器械（2个）。</span></section><section><br  /></section><section><p><img src="image/20201014/d0dbc4cccfee1def73fd9cc4c8672fad_8.jpg" /></p></section><section><p><img src="image/20201014/d85a0d0d4b919e556e51594fa5781c52_9.png" /></p><br  /></section><section><br  /></section><section><strong><span>1）进口医疗器械的国家分布</span></strong></section><section><span><br  /></span></section><section><span>12个进口医疗器械产品，分别来自于4个不同的国家，根据数量从高到低排序，依次是美国（6个）、德国（3个）、意大利（2个）和英国（1个）。</span></section><section><p><img src="image/20201014/c7415ddc99698902b32843e638ec94e5_10.png" /></p></section><section><span>图：</span><span>进口产品的国家分布（来源：</span><a data-miniprogram-appid="wxfa5b20c93499db27" data-miniprogram-path="pages/yixiecha/index/index" data-miniprogram-nickname="医疗器械速查" href="" data-miniprogram-type="text" data-miniprogram-servicetype="" href=""><span>智械洞察</span></a><span>）</span></section><section><br  /></section><section><strong><span>2）国产第三类医疗器械的省份分布</span></strong></section><section><span><br  /></span></section><section><span>31个国产第三类医疗器械产品，分布于7个不同的省份。</span><span>本期国产注册产品注册人所在省份品种数量排在前列的分别是北京（19个）和江苏（4个）。</span></section><section><span><br  /></span></section><section><span>表：</span><span>国产第三类产品的省份分布（来源：</span><a data-miniprogram-appid="wxfa5b20c93499db27" data-miniprogram-path="pages/yixiecha/index/index" data-miniprogram-nickname="医疗器械速查" href="" data-miniprogram-type="text" data-miniprogram-servicetype="" href=""><span>智械洞察</span></a><span>）</span></section><section><p><img src="image/20201014/0bd21f12e160453bbb1f98943b18fe77_11.png" /></p></section><section><br  /></section><section><span>显示在地图上的效果如下图所示。</span></section><section><p><img src="image/20201014/c5b227d1713d8fa3c655fdcd02c43511_12.png" /></p></section><section><span>图：</span><span>国产第三类产品注册人所在省份的地图分布（来源：</span><a data-miniprogram-appid="wxfa5b20c93499db27" data-miniprogram-path="pages/yixiecha/index/index" data-miniprogram-nickname="医疗器械速查" href="" data-miniprogram-type="text" data-miniprogram-servicetype="" href=""><span>智械洞察</span></a><span>）</span></section><section><br  /></section><section><strong><span>3）国产第三类医疗器械的城市分布</span></strong></section><section><span><br  /></span></section><section><span>从注册人所在的地级行政区来看，31个国产第三类医疗器械产品，来自于9个不同的城市，如下表所示。</span></section><section><span><br  /></span></section><section><span>表：</span><span>国产第三类产品的城市分布（来源：</span><a data-miniprogram-appid="wxfa5b20c93499db27" data-miniprogram-path="pages/yixiecha/index/index" data-miniprogram-nickname="医疗器械速查" href="" data-miniprogram-type="text" data-miniprogram-servicetype="" href=""><span>智械洞察</span></a><span>）</span></section><section><p><img 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