大兴兴丰大街北京医疗器械二类备案医疗器械三类经营许可证专业代办包下证周期短下证快

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,企业应当提交《授权委托书》 (原件1份)

setting 5) the geographical location map, floor plan, houseproperty right certificate of the business site or the copy of thehouse lease certificate issued by the house lease, which belongs tothe third party logistics of the district medical e,provide the entrustment contract (1 copy,). 6) catalogue ofoperating facilities and e 7) catalogue of operation 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