北京材料 医疗器械网络销售备案,医疗器械二类备案,三类经营许可证代办,十年经验
企业负责人、质量管理人及其他质量管理人员(质量管理员、验收员、售后服务人员等)身份证复印件、工作简历、任职文件、不在相关企业任职的证明材料,技术职称证或学历证书复印件(对无法通过网上查询等方法证明其真实性的大专以上学历证书,申请人应提交其毕业院校出具的学历证明材料)。
(八) 拟设注册地址、仓库地址地理位置图(注明方位、周边街道、门牌号和毗邻建筑等)、平面布置图(注明面积、周边环境、楼层平面和室内布局、区域划分、重要设施设备位置等),房屋设计用途及是否与居住场所设置在同一建筑物等情况的说明及房屋产权证明或者租赁协议。
(九) (九)采购、进货验收、仓储保管、出库复核、质量跟踪和不良事件报告制度及其他各项医疗器械
经营质量管理制度目录(十)办
How to handle the business license of class III medical devices
1. The business license of Class III medical devices is handled as follows:
(1) The applicant shall submit the application materials to the relevant departments;
(2) Relevant departments shall accept the application of the applicant;
(3) Investigate the actual site and audit the products;
(4) Grant the issuance of a class III medical device license.
Three kinds of medical devices as the highest risk in the medical device classification category, strictly by the supervision and management, but for many families of three kinds of medical devices, many basic problems is not fully grasp, today we will take a look, what are three business scope of medical devices? How to apply for the three types of medical equipment business license again!