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
rprise dealing with the medical device business license, 9) Whenapplying for the application materials of the enterprise, thehandling person is not the legal representative or the person incharge of the enterprise, the enterprise shall submit the power ofattorney (1 original) 10) Self-guarantee statement of theauthenticity of the application materials, including the catalogueof the application materials and the enterprise's commitment tobear the legal liability if there is any false material (1original). 3. After successful site submission, go to the site forinvestigation, and the site materials should be submitted 1) Jobresponsibilities 2) Working procedures 3) Company system 4)Supplier files 5) Training records 6) New laws and regulations
