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
6）新法律法规
7）员工档案等
现场核查成功后一周内就可以拿证了。
edical equipment, provide the entrustment contract (1 copy,). 6)Catalogue of operating facilities and equipment 7) Catalogue ofoperation quality management system, working procedures and otherdocuments; 8) Basic information introduction and functiondescription of the computer information management system installedby the enterprise dealing with the medical device business license,9) When applying for the application materials of the enterprise,the handling person is not the legal representative or the personin charge of the enterprise, the enterprise shall submit the powerof attorney (1 original) 10) Self-guarantee statement of theauthenticity of the application materials, including the catalogueof the application materials and the enterprise's commitment tobear legal liability if there is any false material (1 original).3. After successful site submission, go to the site forinvestigation, and materials should be submitted on site 1) Jobresponsibilities 2) Working procedures 3) Company system 4)Supplier files 5) Training records 6) New laws and regulations 7)Employee files, etc You can get the certificate within a week afterthe successful on-site verification.
