6．企業真實性保證材料（原件1份）。（內容包含：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，企業應當提交《授權委托書》

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

證，根據相關法律規定，國家食品藥品監督管理局逐步推行醫療器械經營質量規范管理制度。醫療器械經營質量管理規范由國家食品藥品監管管理局組織制定。

三類醫療器械經營許可證辦理所需大致資料:

1、企業經營執照;2、企業負責人以及質檢人員和技術人員的身份、學歷、職稱證明;3、經營場所證明以及地理位置圖。

三類醫療器械經營許可證辦理之后需要明確的幾個注意事項

1、醫療器械經營許可證的有效期只有5年。有效期屆滿需要延續的，醫療器械經營企業應當在有效期屆滿6個月前，向原發證部門提出《醫療器械經營許可證》延續申請。

ical 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 State Food and Drug Administration. General information required for handling the business license of Class III medical devices: 1. Bu