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
the business License) (photocopy) 3) Copy of the identitycertificate, educational background or professional titlecertificate of the legal representative, the person in charge ofthe enterprise and the person in charge of quality; 4.) Descriptionof organization structure and department setting 5) Thegeographical location map, floor plan, house property rightcertificate of the business site or the copy of the house leasecertificate issued by the house lease, which belongs to the thirdparty logistics of the entrusted district medical equipment,provide the entrustment contract (1 copy,). 6) Catalogue ofoperating facilitie
