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

證，根據(jù)相關(guān)法律規(guī)定，國(guó)家食品藥品監(jiān)督管理局逐步推行醫(yī)療器械經(jīng)營(yíng)質(zhì)量規(guī)范管理制度。醫(yī)療器械經(jīng)營(yíng)質(zhì)量管理規(guī)范由國(guó)家食品藥品監(jiān)管管理局組織制定。

三類(lèi)醫(yī)療器械經(jīng)營(yíng)許可證辦理所需大致資料:

1、企業(yè)經(jīng)營(yíng)執(zhí)照;2、企業(yè)負(fù)責(zé)人以及質(zhì)檢人員和技術(shù)人員的身份、學(xué)歷、職稱(chēng)證明;3、經(jīng)營(yíng)場(chǎng)所證明以及地理位置圖。

三類(lèi)醫(yī)療器械經(jīng)營(yíng)許可證辦理之后需要明確的幾個(gè)注意事項(xiàng)

 medical device license includes: medical electronic instruments and e, medical optical instruments, instruments and endoscope e, medical magnetic resonance e, medical X-ray e, operating room, emergency room, medical room e and e. The sale of medical devices must be applied for the business license Certificate, according to the relevant laws and regulations, the State Food and Drug Administration has gradually implemented the standard management system of medical device business. The management standards for medical devices shall be formulated by the S