北京星期三企业管理咨询有限公司业务部
工商注册 , 资质审批 , 代理记账 , 建委资质 , 舞美资质 , 拍卖资质
朝阳奥林匹克公园北京医疗器械三类经营许可证可全包代办专业快捷包下证

(1)申请人提交申请资料到相关部门;
(2)相关部门受理申请人的申请;
(3)到实际场地进行勘察以及对产品进行审核;
(4)准予颁发三类医疗器械许可证。
2、法律依据:《医疗器械监督管理条例》第十四条
第一类医疗器械产品备案和申请第二类、第三类医疗器械产品注册,应当提交下列资料:
(一)产品风险分析资料;
(二)产品技术要求;
(三)产品检验报告;
(四)临床评价资料;
(五)产品说明书以及标签样稿;
(六)与产品研制、生产有关的质量管理体系文件;
的企业还需要准备库房 可全程免费指导办理流程,提供质量管理员,也可托管办理,专业速度快速Zui快3天

nt departments shall accept the application; (3) investigate the actual site and review the products; (4) grant the issuance of the third-class medical device license.2. Legal basis: Article 14 of the Regulations on Supervision and Administration of Medical Devices for the filing of Class I medical devices and application for the registration of Class II and Class III medical devices shall submit the following materials: (1) product risk analysis data; (2); (2) product technical requirements; (3) product inspection report; (4) product evaluation data; (5) clinical evaluation data; (5) product instructions and label samples; (6) quality management system documents related to product development and production; prepare the warehouse and provide quality administrators for 3 days


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