4．企業(yè)基本情況（原件1份）。（內(nèi)容包含：組織機(jī)構(gòu)與部門(mén)設(shè)置說(shuō)明、經(jīng)營(yíng)場(chǎng)所、庫(kù)房的地理位置圖、平面圖（注明面積）、庫(kù)房的產(chǎn)權(quán)證明及使用權(quán)證明復(fù)印件、（委托貯存的，應(yīng)提交經(jīng)營(yíng)場(chǎng)所地理位置圖、平面圖（注明面積）和與被委托方簽署的書(shū)面協(xié)議復(fù)印件、被委托方的《醫(yī)療器械經(jīng)營(yíng)許可證》復(fù)印件）

5.企業(yè)設(shè)施設(shè)備情況（原件1份）。（內(nèi)容包含：經(jīng)營(yíng)設(shè)施、設(shè)備目錄、經(jīng)營(yíng)質(zhì)量管理制度、工作程序等文件目錄、計(jì)算機(jī)信息管理系統(tǒng)基本情況介紹和功能說(shuō)明）（原件1份）

6．企業(yè)真實(shí)性保證材料（原件1份）。（內(nèi)容包含：申報(bào)材料真實(shí)性的自我保證聲明，并對(duì)材料作出如有虛假承擔(dān)法律責(zé)任的承諾、凡申請(qǐng)企業(yè)申報(bào)材料時(shí)，具體辦理人員不是法定代表人或負(fù)責(zé)人本人的，企業(yè)應(yīng)當(dāng)提交《授權(quán)委托書(shū)》

三類(lèi)醫(yī)療器械許可證經(jīng)營(yíng)范圍包括:醫(yī)用電子儀器設(shè)備，醫(yī)用光學(xué)器具、儀器及內(nèi)窺鏡設(shè)備，醫(yī)用磁共振設(shè)備，醫(yī)用X射線(xiàn)設(shè)備，手術(shù)室、急救室、診療室設(shè)備及器具。售賣(mài)醫(yī)療器械必須辦理經(jīng)營(yíng)許可

rise (1 original copy).(Content includes: organization and department set instructions, premises, warehouse location map, plan (indicate area), warehouse of property certificate and use right certificate copy, (entrust storage, should be submitted to the site location, plan (indicate area) and the written agreement signed with the principal, the principal copy of the medical device business license) 5. Enterprise facilities and e information (1 original copy).(Contents include: business facilities, e catalogue, business management system, working procedures and other documents catalogue, basic information introduction of computer information