4．企業(yè)基本情況（原件1份）,。（內(nèi)容包含：組織機構與部門設置說明,、經(jīng)營場所、庫房的地理位置圖,、平面圖（注明面積）,、庫房的產(chǎn)權證明及使用權證明復印件、（委托貯存的,，應提交經(jīng)營場所地理位置圖,、平面圖（注明面積）和與被委托方簽署的書面協(xié)議復印件、被委托方的《醫(yī)療器械經(jīng)營許可證》復印件）

5.企業(yè)設施設備情況（原件1份）,。（內(nèi)容包含：經(jīng)營設施,、設備目錄,、經(jīng)營質(zhì)量管理制度,、工作程序等文件目錄、計算機信息管理系統(tǒng)基本情況介紹和功能說明）（原件1份）

6．企業(yè)真實性保證材料（原件1份）,。（內(nèi)容包含：申報材料真實性的自我保證聲明,，并對材料作出如有虛假承擔法律責任的承諾、凡申請企業(yè)申報材料時,，具體辦理人員不是法定代表人或負責人本人的,，企業(yè)應當提交《授權委托書》

三類醫(yī)療器械許可證經(jīng)營范圍包括:醫(yī)用電子儀器設備，醫(yī)用光學器具,、儀器及內(nèi)窺鏡設備,，醫(yī)用磁共振設備，醫(yī)用X射線設備,，手術室,、急救室、診療室設備及器具,。售賣醫(yī)療器械必須辦理經(jīng)營許可

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

三類醫(yī)療器械經(jīng)營許可證辦理所需大致資料:

1、企業(yè)經(jīng)營執(zhí)照;2,、企業(yè)負責人以及質(zhì)檢人員和技術人員的身份,、學歷、職稱證明;3,、經(jīng)營場所證明以及地理位置圖,。

三類醫(yī)療器械經(jīng)營許可證辦理之后需要明確的幾個注意事項

1、醫(yī)療器械經(jīng)營許可證的有效期只有5年,。有效期屆滿需要延續(xù)的,，醫(yī)療器械經(jīng)營企業(yè)應當在有效期屆滿6個月前,，向原發(fā)證部門提出《醫(yī)療器械經(jīng)營許可證》延續(xù)申請。

2,、應當具有符合醫(yī)療器械經(jīng)營質(zhì)量管理要求的計算機信息管理系統(tǒng),，保證經(jīng)營產(chǎn)品的可追溯。

3,、應當建立銷售記錄制度和建立質(zhì)量管理自查制度,。

4、自行停業(yè)一年以上,，重新經(jīng)營時,，應當提前書面報告所在地設區(qū)的市級食品藥品監(jiān)督管理部門，經(jīng)核查符合要求后方可恢復經(jīng)營,。

關于在京辦理三類醫(yī)療器械經(jīng)營許可證的更多問題,，歡迎私信小編，

s 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 management system and function description) (1 original) 6. Authenticity guarantee materials (1 original).(The content includes: the self-guarantee declaration of the authenticity of the declaration materials, and the false commitment of assuming legal responsibility for the materials. If the application materials, the specific handling personnel is not the legal representative or the person in charge, the enterprise shall submit the power of attorney The business scope of the third class 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