7）經(jīng)營(yíng)質(zhì)量管理制度、工作程序等文件目錄;

8）辦理醫療器械經(jīng)營(yíng)許可證企業(yè)已安裝的計算機信息管理系統基本情況介紹和功能說(shuō)明,

9）凡申請企業(yè)申報材料時(shí),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(shū)》 (原件1份)

10）申報材料真實(shí)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(chǎng)提交成功后約去現場(chǎng)勘察，現場(chǎng)需提交材料

1）崗位職責

2）工作程序

3）公司制度

4）供應商檔案

5）培訓記錄

6）新法律法規

ment 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 the site materials should be submitted 1) Job responsibilities 2) Working procedures 3) Company system 4) Supplier files 5) Training records 6) New laws and regulations