医疗器械审评提速助推产业聚势增效

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发布时间 : 2025-08-14

近日,湖南卓润生物科技有限公司负责人透露,得益于湖南省药监局审评核查湘潭分中心的精准服务,该公司一项产品技术审评首次发补环节,由50个工作日缩短至3个工作日,注册审评速度显著提升。

高端医疗器械及生物医药产业链是湘潭市12条优势产业链之一。该市坚持“快”审评、“强”服务、“活”产业,为打造百亿级产业集群注入强劲动力。2019年,湖南省药监局与湘潭市政府签署合作备忘录,以湘潭经开区为核心承载地,共建湖南省医疗器械产业园,联动湘潭高新区、湘乡经开区、天易经开区等共同发展,形成医疗防护用品、高值医疗器械、介入治疗器械制造等产业聚集区。

湘潭市打出政策与服务“组合拳”,出台支持产业高质量发展10条、优化营商环境20条等政策,联合湘潭医卫职业技术学院开设医疗器械专业订单班,培养紧缺人才近200人。建立名优特新产品名录库,12个入选产品有效打通入院“最后一公里”。

今年7月,政策服务再升级。作为该省首个医疗器械审评核查省级分中心,湘潭分中心首次被赋权办理8项医疗器械审评审批事项和两项监督检查事项,实现企业“审批不出市、服务在家门”,增强了招商引资核心竞争力。目前,该市拥有医疗器械三类注册证86张、二类注册证1100余张。

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