北京西城北京医疗器械二类备案医疗器械三类经营许可证专业办理经验丰富全程代办周期短Zui快7天下证

二、提交完毕后接下来需要准备以下资料去现场提交材料

1.）《医疗器械经营许可证申请表》

2）《营业执照正副本原件)(复印件)

3）法定代表人、企业负责人、质量负责人的身份证明、学历或者职称证明复印件；

4.）组织机构与部门设置说明

5）经营场所、库房地址的地理位置图、平面图、房屋产权证明文件或者由房屋租赁所出具的房屋租赁凭证复印件,属仓储委托区疗器械第三方物流的,提供委托合同(复印件1份,).

6）经营设施、设备目录

7）经营质量管理制度、工作程序等文件目录;

8）办理医疗器械经营许可证企业已安装的计算机信息管理系统基本情况介绍和

e issued by the house lease, which belongs to the third party logistics of the district medical equipment, provide the entrustment contract (1 copy,). 6) Catalogue of operating facilities and equipment 7) Catalogue of operation quality management system, working procedures and other documents; 8) Introduce the basic information of the computer information management system installed by the enterprise applying for the medical device business license