二、提交完畢后需要準(zhǔn)備以下資料去現(xiàn)場提交材料

1.）《醫(yī)療器械經(jīng)營許可證申請表》

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)負責(zé)人、質(zhì)量負責(zé)人的身份證明、學(xué)歷或者職稱證明復(fù)印件；

4.）組織機構(gòu)與部門設(shè)置說明

5）經(jīng)營場所、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)已安裝的計算機信息管理系統(tǒng)基本情況介紹和

 of the entrusted district medical e, provide the entrustment contract (1 copy,). 6) Catalogue of operating facilities and e 7) Catalogue of operation management system, working procedures and other documents; 8) Introduce the basic information of the computer information management system installed by the enterprise applying for the medical device business license