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。
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 charge ofthe enterprise, the enterprise shall submit the power of attorney(1 original) 10) Self-guarantee statement of the authenticity ofthe application materials, including the catalogue of theapplication materials and the enterprise's commitment to bear thelegal liability if there is any false material (1 original). 3.After successful site submission, go to the site for investigation,and the site materials should be submitted 1) Job responsibilities2) Working procedures 3) Company system 4) Supplier files 5)Training records 6) New laws and
