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。
ction description of the computer information management systeminstalled by the enterprise applying for the medical devicebusiness license, 9) When applying for the application materials ofthe enterprise, the handling person is not the legal representativeor the person in charge of the enterprise himself, and theenterprise shall submit the power of attorney (1 original) 10)Self-guarantee statement of the authenticity of the applicationmaterials, including the catalogue of the application materials andthe enterprise's commitment to bear legal liability if there is anyfalse material (1 original). 3. After successful site submission,go to the site for investigation, and the site materials should besubmitted 1) Job responsibilities 2) Working procedures 3) Companysystem 4) Supplier files 5) Training records 6) New laws andregulations 7) Employee files, etc You can get the certificatewithin a
