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功能说明,
9）凡申请企业申报材料时,办理人员不是法定代表人或企业负责人本人,企业应当提交《授权委托书》 (原件1份)
10）申报材料真实性的自我保证声明,包括申请材料目录和企业对材料作出如有虚假承担法律责任的承诺(原件1份).
三、现场提交成功后约去现场勘察，现场需提交材料
1）岗位职责
2）工作程序
3）公司制度
4）供应商档案
5）培训记录
5) The geographical location map, floor plan, house propertyright certificate of the business site or the copy of the houselease certificate issued by the house lease, which belongs to thethird party logistics of the entrusted district medical equipment,provide the entrustment contract (1 copy,). 6) Catalogue ofoperating facilities and equipment 7) Catalogue of operationquality management system, working procedures and other documents;8) Basic information introduction and function description of thecomputer information management system installed by the enterprisedealing with the medical device business license, 9) When applyingfor the application materials of the enterprise, the handlingperson is not the legal representative or the person in charge ofthe enterprise, the enterprise shall subm
