CFDA发文：医疗器械审批还要加速！

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                    <p>医药网2月8日讯<strong>　</strong>2016年，是医疗器械审评审批制度改革的攻坚之年，总局器审中心在去年年底的专家座谈会上透露，2016年1-11月，器审中心共接收各类审评任务10416项，完成技术审评10086项，较上年同期增加19%。</p><p>&nbsp;</p><p>　　其中，前11个月，器审中心共收到创新医疗器械产品特别审批申请171项，完成审查144项，审查通过44项（进口产品5项）。</p><p>&nbsp;</p><p>　　此外，器审中心采取“提前介入、专人负责”的模式，为创新产品申报<strong><span style="color: rgb(0, 153, 102);">企业</span></strong>提供先期指导，完成了骨科手术导航定位系统等10项创新产品的技术审评，推进了创新医疗器械研发上市进程。</p><p>&nbsp;</p><p>　　而2017年度，医疗器械审评审批改革有望再次提速，“创新医疗器械”、以及总局于2016年底推出的“优先审批医疗器械”，或继续成为最大受益体。</p><p>&nbsp;</p><p>　　2017年2月7日，国家药监总局发布《<strong><span style="color: rgb(0, 153, 102);">医疗器械</span></strong>审评沟通交流管理办法（试行）》（以下简称《办法》），该《办法》自发布之日起施行。</p><p>&nbsp;</p><p>　　同去年6月发布的《药物研发与技术审评沟通交流管理办法（试行）》一样，该《办法》也明确以会议为载体，在申请人与药监审评人员之间建立沟通交流桥梁，从而提升审评工作效率。</p><p>&nbsp;</p><p>　　《办法》规定，创新医疗器械在注册申请受理前和技术审评阶段，优先审批医疗器械在技术审评阶段，申请人均可以提出，与器审中心就注册申请事项进行会议沟通交流。其中，创新医疗器械可以讨论的包括重大技术问题、重大安全性问题，也包括临床试验方案和试验结果等。</p><p>&nbsp;</p><p>　　很明显，这是国家扶持创新医疗器械和优先审批医疗器械的又一举措，《办法》也并未惠及到所有医疗器械。</p><p>&nbsp;</p><p>　　《办法》施行以后，尽管总局器审中心仍然面临人手数量不足困境，创新和优先审批类医疗器械产品的获批上市速度却也有望再加快。</p><p><br  /></p><p style="text-indent: 0em; 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