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海淀四季青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

发布时间:2023-12-19        浏览次数:17        返回列表
前言:医疗器械三类,注册公司
海淀四季青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

三类医疗器械经营许可证如何办理
1、三类医疗器械经营许可证办理方式如下:
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;(4)经营场所、仓库的地理位置图、平面图(注明面积)、房屋产权证明或者租赁协议复印件;(5)企业产品质量管理制度文件及储存设施、设备目录。(6)对于办理

the applicant submits the application materials to the relevant departments; (2) the relevant department accepts the application of the applicant; (3) investigate the actual site and review the product; (4) grant the issuance of the Class III 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 III medical devices, the following data shall be submitted: (1) product risk analysis data; (2) product technical requirements; (2) product technical requirements; (3) product inspection report; (4) geographical location map and plan of business premises and warehouse, (indicated area), copies of house property certificate or lease agreement; (5) documents of product quality management system and catalogue of storage facilities and equipment.(6) For the handling


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