1.）《醫(yī)療器械經(jīng)營許可證申請(qǐng)表》

2）《營業(yè)執(zhí)照正副本原件)(復(fù)印件)

3）法定代表人,、企業(yè)負(fù)責(zé)人,、質(zhì)量負(fù)責(zé)人的身份證明、學(xué)歷或者職稱證明復(fù)印件,；

4.）組織機(jī)構(gòu)與部門設(shè)置說明

5）經(jīng)營場(chǎng)所,、庫房地址的地理位置圖,、平面圖、房屋產(chǎn)權(quán)證明文件或者由房屋租賃所出具的房屋租賃憑證復(fù)印件,屬倉儲(chǔ)委托區(qū)療器械第三方物流的,提供委托合同(復(fù)印件1份,).

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)

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 personnel is not the legal representative or the person in charge of the enterprise himself, and the enterprise shall