药监局2019工作报告发布！江苏甩开北上广成医疗器械注册大省

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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>据药监局最新发布的医疗器械注册公告显示，2019年，国家药监局依职责共受理医疗器械首次注册、延续注册和许可事项变更注册申请9104项，与2018年相比注册受理项目增加37.8%。</span></section><section><span><br  /></span></section><section><span>受理境内第三类医疗器械注册申请3511项，受理进口医疗器械注册申请5593项。</span></section><section><span><br  />按注册品种区分，医疗器械注册申请5877项，体外诊断试剂注册申请3227项。</span></section><section><span><br  />按注册形式区分，首次注册申请1693项，占全部医疗器械注册申请的18.6%；延续注册申请5081项，占全部医疗器械注册申请的55.8%；许可事项变更注册申请2330项，占全部医疗器械注册申请的25.6%。</span></section><section><span><br  /></span></section><section><p><img src="image/20201014/02859364841af226738915fe9dbc167e_2.png" /></p></section><section><br  /></section><section><strong><span>医疗器械注册受理情况<br  /></span></strong></section><section><strong><span><br  /></span></strong></section><section><br  /></section><section><strong><span>1.境内第三类医疗器械注册受理情况</span></strong></section><section><span><br  />境内第三类医疗器械注册受理共3511项，与2018年相比大幅增加47.4%。其中，医疗器械注册申请2154项，体外诊断试剂注册申请1357项。</span></section><section><br  /></section><section><span>从注册形式看，首次注册1055项，占全部境内第三类医疗器械注册申请数量30.0%；延续注册1777项，占全部境内第三类医疗器械注册申请数量的50.6%；许可事项变更679项，占全部境内第三类医疗器械注册申请数量的19.3%。</span></section><section><span><br  /></span></section><section><p><img src="image/20201014/021443a3ff2c1a82654a9b9f33c85abe_3.png" /></p></section><section><br  /></section><section><strong><span>2.进口第二类医疗器械注册受理情况</span></strong></section><section><span><br  /></span></section><section><br  /></section><section><span>进口第二类医疗器械注册受理共3053项，与2018年相比增加43.7%。其中医疗器械注册申请1559项，体外诊断试剂注册申请1494项。<br  /></span></section><section><span><br  /></span></section><section><span>从注册形式看，首次注册358项，占全部进口第二类医疗器械注册申请数量的11.7%；延续注册1847项，占全部进口第二类医疗器械注册申请数量的60.5%；许可事项变更848项，占全部进口第二类医疗器械注册申请数量的27.8%。</span></section><section><span><br  /></span></section><section><p><img src="image/20201014/83698c64db3d1af1caf6f5e8ec0df6d5_4.png" /></p></section><section><br  /><strong><span>3.进口第三类医疗器械注册受理情况</span></strong></section><section><span><br  /></span></section><section><br  /></section><section><span>进口第三类医疗器械注册受理共2540项，与2018年相比增加20.9%。其中医疗器械注册申请2164项，体外诊断试剂注册申请376项。</span></section><section><span><br  /></span></section><section><br  /></section><section><span>从注册形式看，首次注册280项，占全部进口第三类医疗器械注册申请数量的11.0%；延续注册1457项，占全部进口第三类医疗器械注册申请数量的57.4%；许可事项变更803项，占全部进口第三类医疗器械注册申请数量的31.6%。</span></section><section><span><br  /></span></section><section><p><img src="image/20201014/cc03152c02679213c37040f53972f1a8_5.png" /></p></section><section><br  /></section><section><span><br  /></span></section><section><strong><span>医疗器械注册审批情况</span></strong><span><br  /></span></section><section><span><br  /></span></section><section><br  /></section><section><span>2019年，国家药监局共批准医疗器械首次注册、延续注册和变更注册8471项，与2018年相比注册批准总数量增长53.2%。其中，首次注册1726项，延续注册4504项，许可事项变更2241项。<br  /><br  />2019年，企业自行撤回注册申请210项，自行注销注册证书66项。</span></section><section><span><br  /></span></section><section><br  /></section><section><strong><span>近6年国家药监局批准医疗器械注册情况</span></strong></section><section><p><img src="image/20201014/93aa98cbbd968d048410282b8fc7ca0b_6.png" /></p></section><section><br  /><span>2019年，国家药监局批准境内第三类医疗器械注册3179项，与2018年相比增加86.0%，进口医疗器械5292项，与2018年相比增加38.6%。</span></section><section><span><br  /></span></section><section><br  /></section><section><span>按照注册品种区分，医疗器械5226项，占全部医疗器械注册数量的61.7%；体外诊断试剂3245项，占全部医疗器械注册数量的38.3%。</span></section><section><br  /></section><section><span>按照注册形式区分，首次注册1726项，占全部医疗器械注册数量的20.4%；延续注册4504项，占全部医疗器械注册数量的53.2%；许可事项变更注册2241项，占全部医疗器械注册数量的26.4%。<br  /></span></section><section><span><br  /></span></section><section><p><img src="image/20201014/1dd9bbd87ee87d7e28d844c8a8985f86_7.png" /></p></section><section><br  /><strong><span>1.境内第三类医疗器械注册审批情况</span></strong><span></span></section><section><span><br  />境内第三类医疗器械注册3179项。其中，医疗器械2014项，体外诊断试剂1165项。</span></section><section><span><br  /></span></section><section><br  /></section><section><span>从注册形式看，首次注册1067项，占全部境内第三类医疗器械注册数量的33.6%，延续注册1465项，占全部境内第三类医疗器械注册数量的46.1%；许可事项变更注册647项，占全部境内第三类医疗器械注册数量的20.4%。</span></section><section><span><br  /></span></section><p><p><img src="image/20201014/af05056bec99977b001e3a60761d886b_8.png" /></p></p><p><br  /></p><section><strong><span>2.进口第二类医疗器械注册审批情况</span></strong></section><section><span><br  />进口第二类医疗器械注册2754项。其中，医疗器械注册1521项，体外诊断试剂注册1233项。</span></section><section><span><br  /></span></section><section><br  /></section><section><span>从注册形式看，首次注册375项，占全部进口第二类医疗器械注册数量的13.6%；延续注册1622项，占全部进口第二类医疗器械注册数量的58.9%；许可事项变更注册757项，占全部进口第二类医疗器械注册数量的27.5%。</span></section><section><span><br  /></span></section><p><p><img src="image/20201014/eb4b7b41605c810de934d5b2053842a3_9.png" /></p></p><section><br  /><strong><span>3.进口第三类医疗器械注册审批情况</span></strong><span></span></section><section><span><br  />进口第三类医疗器械注册2538项。其中，医疗器械注册2206项，体外诊断试剂注册332项。</span></section><section><span><br  /></span></section><section><br  /></section><section><span>从注册形式看，首次注册284项，占全部进口第三类医疗器械注册数量的11.2%；延续注册1417项，占全部进口第三类医疗器械注册数量的55.8%；许可事项变更注册837项，占全部进口第三类医疗器械注册数量的33.0%。<br  /></span></section><section><span><br  /></span></section><p><p><img src="image/20201014/ec88cde53d60c3503d45ff9a8ef93365_10.png" /></p></p><p><span>首次注册项目月度审批情况<br  /></span></p><p><span><br  /></span></p><p><br  /></p><p><span>2019年，国家药监局共批准医疗器械首次注册1726项，月度审批情况见图。</span></p><p><span><br  /></span></p><p><p><img src="image/20201014/74ee1a100fc49a3fb34fcb7d734e424b_11.png" /></p></p><p><strong><span>具体批准品种种类分析</span></strong></p><p><span><br  /></span></p><p><br  /></p><section><span>注册的境内第三类医疗器械，除体外诊断试剂外，共涉及《医疗器械分类目录》中19个子目录的产品。<br  /></span></section><section><br  /><span>注册数量前五位的境内第三类医疗器械是：无源植入器械、注输、护理和防护器械、神经和心血管手术器械、医用成像器械和有源手术器械。</span></section><section><span><br  /></span></section><p><p><img src="image/20201014/f9bee511f2283b59fbfc3c5190bf68db_12.png" /></p></p><p><span>&nbsp;</span></p><section><span>注册的进口医疗器械，除体外诊断试剂外，共涉及《医疗器械分类目录》中23个子目录的产品。</span></section><section><br  /></section><section><span>注册数量前五位的进口医疗器械，主要是：医用成像器械、口腔科器械、无源植入器械、临床检验器械、神经和心血管手术器械。</span></section><section><span><br  /></span></section><p><p><img src="image/20201014/f256b9b0fac9b91c60512d952046841c_13.png" /></p></p><p><br  /></p><p><strong><span>进口医疗器械国别情况</span></strong><span><br  /></span></p><p><br  /></p><section><span>2019年，美国、德国、日本、韩国、瑞士医疗器械在中国医疗器械进口产品首次注册数量排前5位，注册产品数量约占2019年进口产品首次注册总数量的75.4%，与2018年相比基本持平。</span></section><section><span><br  /></span></section><p><p><img src="image/20201014/2c4196baab870e34dbc049dbae980c23_14.png" /></p></p><p><br  /></p><p><strong><span>境内第三类医疗器械省份分析</span></strong><span></span><br  /></p><p><br  /></p><section><span>从2019年境内第三类医疗器械注册情况看，相关注册产品生产企业主要集中在沿海经济较发达省份。其中，江苏、北京、广东、上海、浙江是境内第三类医疗器械首次注册数量排前五名的省份，占2019年境内第三类医疗器械首次注册数量的69.1%，与2018年相比略有增加。</span></section><section><span><br  /></span></section><p><p><img src="image/20201014/f230abc153d1aa04c9ce8d09a2fb0d51_15.png" /></p></p><p><br  /></p><p><strong><span>其他注册管理情况</span></strong><span><br  /></span></p><p><br  /></p><section><strong><span>(1).境内第二类医疗器械注册审批情况</span></strong></section><section><span><br  />2019年，各省级药品监管部门共批准境内第二类医疗器械注册17017项，与2018年相比增加53.4%。其中首次注册6211项，占全部境内第二类医疗器械注册数量的36.5%；延续注册7153项，占全部境内第二类医疗器械注册数量的42.0%；许可事项变更注册3653项，占全部境内第二类医疗器械注册数量的21.5%。境内第二类医疗器械分项注册情况见图。</span></section><p><span>&nbsp;</span></p><p><p><img src="image/20201014/76a2a17f49b1c3f561b3b7ab58911c31_16.png" /></p></p><section><br  /><span>从注册情况看，江苏、北京、广东、浙江、河南、山东、上海、湖南、河北、重庆10省（直辖市）注册的境内第二类医疗器械数量较多。第二类医疗器械注册具体数据见表1及图。</span></section><section><br  /></section><table height="901" cellspacing="0"><tbody><tr><td width="114" valign="center"><p><span>省份</span></p></td><td width="80" valign="center"><p><span>首次注册</span></p></td><td width="80" valign="center"><p><span>延续注册</span></p></td><td width="109" valign="center"><p><span>许可事项变更注册</span></p></td><td width="107" valign="center"><p><span>总计</span></p></td></tr><tr><td width="114" valign="center"><p><span>北京</span></p></td><td width="80" valign="center"><p><span>332</span></p></td><td width="80" valign="center"><p><span>1249</span></p></td><td width="130" valign="center"><p><span>803</span></p></td><td width="107" valign="center"><p><span>2384</span></p></td></tr><tr><td width="114" valign="center"><p><span>天津</span></p></td><td width="80" valign="center"><p><span>103</span></p></td><td width="80" valign="center"><p><span>174</span></p></td><td width="130" valign="center"><p><span>118</span></p></td><td width="107" valign="center"><p><span>395</span></p></td></tr><tr><td width="114" valign="center"><p><span>河北</span></p></td><td width="80" valign="center"><p><span>217</span></p></td><td width="80" valign="center"><p><span>246</span></p></td><td width="130" valign="center"><p><span>141</span></p></td><td width="107" valign="center"><p><span>604</span></p></td></tr><tr><td width="114" valign="center"><p><span>山西</span></p></td><td width="80" valign="center"><p><span>64</span></p></td><td width="80" valign="center"><p><span>32</span></p></td><td width="130" valign="center"><p><span>12</span></p></td><td width="107" valign="center"><p><span>108</span></p></td></tr><tr><td width="114" valign="center"><p><span>内蒙古</span></p></td><td width="80" valign="center"><p><span>1</span></p></td><td width="80" valign="center"><p><span>3</span></p></td><td width="130" valign="center"><p><span>4</span></p></td><td width="107" valign="center"><p><span>8</span></p></td></tr><tr><td width="114" valign="center"><p><span>辽宁</span></p></td><td width="80" valign="center"><p><span>116</span></p></td><td width="80" valign="center"><p><span>80</span></p></td><td width="130" valign="center"><p><span>51</span></p></td><td width="107" valign="center"><p><span>247</span></p></td></tr><tr><td width="114" valign="center"><p><span>吉林</span></p></td><td width="80" valign="center"><p><span>180</span></p></td><td width="80" valign="center"><p><span>62</span></p></td><td width="130" valign="center"><p><span>96</span></p></td><td width="107" valign="center"><p><span>338</span></p></td></tr><tr><td width="114" valign="center"><p><span>黑龙江</span></p></td><td width="80" valign="center"><p><span>21</span></p></td><td width="80" valign="center"><p><span>49</span></p></td><td width="130" valign="center"><p><span>6</span></p></td><td width="107" valign="center"><p><span>76</span></p></td></tr><tr><td width="114" valign="center"><p><span>上海</span></p></td><td width="80" valign="center"><p><span>167</span></p></td><td width="80" valign="center"><p><span>593</span></p></td><td width="130" valign="center"><p><span>159</span></p></td><td width="107" valign="center"><p><span>919</span></p></td></tr><tr><td width="114" valign="center"><p><span>江苏</span></p></td><td width="80" valign="center"><p><span>1202</span></p></td><td width="80" valign="center"><p><span>913</span></p></td><td width="130" valign="center"><p><span>373</span></p></td><td width="107" valign="center"><p><span>2488</span></p></td></tr><tr><td width="114" valign="center"><p><span>浙江</span></p></td><td width="80" valign="center"><p><span>401</span></p></td><td width="80" valign="center"><p><span>727</span></p></td><td width="130" valign="center"><p><span>314</span></p></td><td width="107" valign="center"><p><span>1442</span></p></td></tr><tr><td width="114" valign="center"><p><span>安徽</span></p></td><td width="80" valign="center"><p><span>123</span></p></td><td width="80" valign="center"><p><span>85</span></p></td><td width="130" valign="center"><p><span>48</span></p></td><td width="107" valign="center"><p><span>256</span></p></td></tr><tr><td width="114" valign="center"><p><span>福建</span></p></td><td width="80" valign="center"><p><span>60</span></p></td><td width="80" valign="center"><p><span>85</span></p></td><td width="130" valign="center"><p><span>32</span></p></td><td width="107" valign="center"><p><span>177</span></p></td></tr><tr><td width="114" valign="center"><p><span>江西</span></p></td><td width="80" valign="center"><p><span>216</span></p></td><td width="80" valign="center"><p><span>147</span></p></td><td width="130" valign="center"><p><span>31</span></p></td><td width="107" valign="center"><p><span>394</span></p></td></tr><tr><td width="114" valign="center"><p><span>山东</span></p></td><td width="80" valign="center"><p><span>248</span></p></td><td width="80" valign="center"><p><span>615</span></p></td><td width="130" valign="center"><p><span>134</span></p></td><td width="107" valign="center"><p><span>997</span></p></td></tr><tr><td width="114" valign="center"><p><span>河南</span></p></td><td width="80" valign="center"><p><span>401</span></p></td><td width="80" valign="center"><p><span>413</span></p></td><td width="130" valign="center"><p><span>437</span></p></td><td width="107" valign="center"><p><span>1251</span></p></td></tr><tr><td width="114" valign="center"><p><span>湖北</span></p></td><td width="80" valign="center"><p><span>124</span></p></td><td width="80" valign="center"><p><span>149</span></p></td><td width="130" valign="center"><p><span>62</span></p></td><td width="107" valign="center"><p><span>335</span></p></td></tr><tr><td width="114" valign="center"><p><span>湖南</span></p></td><td width="80" valign="center"><p><span>488</span></p></td><td width="80" valign="center"><p><span>179</span></p></td><td width="130" valign="center"><p><span>82</span></p></td><td width="107" valign="center"><p><span>749</span></p></td></tr><tr><td width="114" valign="center"><p><span>广东</span></p></td><td width="80" valign="center"><p><span>875</span></p></td><td width="80" valign="center"><p><span>875</span></p></td><td width="130" valign="center"><p><span>501</span></p></td><td width="107" valign="center"><p><span>2251</span></p></td></tr><tr><td width="114" valign="center"><p><span>广西</span></p></td><td width="80" valign="center"><p><span>103</span></p></td><td width="80" valign="center"><p><span>71</span></p></td><td width="130" valign="center"><p><span>47</span></p></td><td width="107" valign="center"><p><span>221</span></p></td></tr><tr><td width="114" valign="center"><p><span>海南</span></p></td><td width="80" valign="center"><p><span>9</span></p></td><td width="80" valign="center"><p><span>11</span></p></td><td width="130" valign="center"><p><span>12</span></p></td><td width="107" valign="center"><p><span>32</span></p></td></tr><tr><td width="114" valign="center"><p><span>重庆</span></p></td><td width="80" valign="center"><p><span>290</span></p></td><td width="80" valign="center"><p><span>114</span></p></td><td width="130" valign="center"><p><span>47</span></p></td><td width="107" valign="center"><p><span>451</span></p></td></tr><tr><td width="114" valign="center"><p><span>四川</span></p></td><td width="80" valign="center"><p><span>184</span></p></td><td width="80" valign="center"><p><span>97</span></p></td><td width="130" valign="center"><p><span>92</span></p></td><td width="107" valign="center"><p><span>373</span></p></td></tr><tr><td width="114" valign="center"><p><span>贵州</span></p></td><td width="80" valign="center"><p><span>90</span></p></td><td width="80" valign="center"><p><span>39</span></p></td><td width="130" valign="center"><p><span>7</span></p></td><td width="107" valign="center"><p><span>136</span></p></td></tr><tr><td width="114" valign="center"><p><span>云南</span></p></td><td width="80" valign="center"><p><span>65</span></p></td><td width="80" valign="center"><p><span>11</span></p></td><td width="130" valign="center"><p><span>4</span></p></td><td width="107" valign="center"><p><span>80</span></p></td></tr><tr><td width="114" valign="center"><p><span>西藏</span></p></td><td width="80" valign="center"><p><span>4</span></p></td><td width="80" valign="center"><p><span>2</span></p></td><td width="130" valign="center"><p><span>0</span></p></td><td width="107" valign="center"><p><span>6</span></p></td></tr><tr><td width="114" valign="center"><p><span>陕西</span></p></td><td width="80" valign="center"><p><span>59</span></p></td><td width="80" valign="center"><p><span>76</span></p></td><td width="130" valign="center"><p><span>22</span></p></td><td width="107" valign="center"><p><span>157</span></p></td></tr><tr><td width="114" valign="center"><p><span>甘肃</span></p></td><td width="80" valign="center"><p><span>41</span></p></td><td width="80" valign="center"><p><span>17</span></p></td><td width="130" valign="center"><p><span>13</span></p></td><td width="107" valign="center"><p><span>71</span></p></td></tr><tr><td width="114" valign="center"><p><span>青海</span></p></td><td width="80" valign="center"><p><span>19</span></p></td><td width="80" valign="center"><p><span>1</span></p></td><td width="130" valign="center"><p><span>2</span></p></td><td width="107" valign="center"><p><span>22</span></p></td></tr><tr><td width="114" valign="center"><p><span>宁夏</span></p></td><td width="80" valign="center"><p><span>3</span></p></td><td width="80" valign="center"><p><span>7</span></p></td><td width="130" valign="center"><p><span>2</span></p></td><td width="107" valign="center"><p><span>12</span></p></td></tr><tr><td width="114" valign="center"><p><span>新疆</span></p></td><td width="80" valign="center"><p><span>5</span></p></td><td width="80" valign="center"><p><span>31</span></p></td><td width="130" valign="center"><p><span>1</span></p></td><td width="107" valign="center"><p><span>37</span></p></td></tr></tbody></table><p><span>表1&nbsp;境内第二类医疗器械注册表</span></p><p><span><br  /></span></p><p><p><img src="image/20201014/822304245016a33ac3362471f0d0ca5d_17.png" /></p></p><p><span>图:&nbsp;各省第二类医疗器械注册数据图</span></p><section><br  /></section><section><strong><span>(2).第一类医疗器械备案情况</span></strong><span></span></section><section><span><br  />2019年，国家药监局依职责共办理进口第一类医疗器械备案数量1383项，与2018年相比减少20.7%。全国设区的市级药品监管部门依职责共办理境内第一类医疗器械备案数量16754项，与2018年相比减少2.4%。<br  /><br  /><strong>(3).登记事项变更情况</strong></span></section><section><span><br  />2019年，国家药监局依职责共办理进口第二、三类和境内第三类医疗器械登记事项变更4382项。与2018年相比减少42.8%。<br  /><br  />其中，境内第三类医疗器械登记事项变更1701项，进口第二类、三类医疗器械登记事项变更2681项。<br  /><br  />各省级药品监管部门依职责共办理境内第二类医疗器械登记事项变更7040项，与2018年相比增加10.8%。<br  /><br  /></span><span>注：本报告的数据统计自2019年1月1日至2019年12月31日。</span></section><p><span>报告来源：国家药品监督管理局《2019年度医疗器械注册工作报告》</span></p><p><span>转载来源：IVD从业者</span><br  /></p><p><br  /></p><section data-role="outer" label="Powered by gulangu"><section data-role="paragraph" data-color="#757576"><section data-role="paragraph"><section><section><section 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