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(yī)療器械經(jīng)營(yíng)許可證企業(yè)已安裝的計(jì)算機(jī)信息管理系統(tǒng)基本情況介紹和功能說(shuō)明,

9）凡申請(qǐng)企業(yè)申報(bào)材料時(shí),辦理人員不是法定代表人或企業(yè)負(fù)責(zé)人本人,企業(yè)應(yīng)當(dāng)提交《授權(quán)委托書》 (原件1份)

10）申報(bào)材料真實(shí)性的自我保證聲明,包括申請(qǐng)材料目錄和企業(yè)對(duì)材料作出如有虛假承擔(dān)法律責(zé)任的承諾(原件1份).

三、現(xiàn)場(chǎng)提交成功后約去現(xiàn)場(chǎng)勘察，現(xiàn)場(chǎng)需提交材料

1）崗位職責(zé)

2）工作程序

3）公司制度

4）供應(yīng)商檔案

5）培訓(xùn)記錄

6）新法律法規(guī)

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