6）經(jīng)營設(shè)施、設(shè)備目錄

7）經(jīng)營質(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

ent 7) Catalogue of operation management system, working procedures and other documents; 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 himself, and 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 com