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
stem, working procedures and other documents; 8) Basicinformation introduction and function description of the computerinformation management system installed by the enterprise dealingwith the medical device business license, 9) When applying for theapplication materials, the handling person is not the legalrepresentative or the person in charge of the enterprise himself,and the enterprise shall submit the power of attorney (1 original)10) Self-guarantee statement of the aut
