7）經營質量管理制度、工作程序等文件目錄;

8）辦理醫(yī)療器械經營許可證企業(yè)已安裝的計算機信息管理系統(tǒng)基本情況介紹和功能說明,

9）凡申請企業(yè)申報材料時,辦理人員不是法定代表人或企業(yè)負責人本人,企業(yè)應當提交《授權委托書》 (原件1份)

10）申報材料真實性的自我保證聲明,包括申請材料目錄和企業(yè)對材料作出如有虛假承擔法律責任的承諾(原件1份).

三、現場提交成功后約去現場勘察，現場需提交材料

1）崗位職責

2）工作程序

3）公司制度

8) Basic information introduction and function description of the computer information management system installed by 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 person in charge of the enterprise, the enterprise shall submit the power of attorney (1 original) 10) Self-guarantee statement of the authenticity of the application materials, including the catalogue of the application materials and the enterprise's commitment to bear legal liability if there is any false material (1 original). 3. After successful site submission, go to the site for investigation and submit materials on site 1) Job