第三類醫(yī)療器械許可的經營范圍包括：醫(yī)用電子設備、醫(yī)用光學設備、儀器和內鏡設備、醫(yī)用磁共振設備、醫(yī)用X射線設備、手術室、急診室和診室的設備和器具。根據售賣醫(yī)療器械必須辦理經營許可證，,國家相關法律法規(guī)，美國食品藥品監(jiān)督管理局逐步推行醫(yī)療器械管理質量標準化管理體系。醫(yī)療器械經營質量管理規(guī)范由國家美國食品藥品監(jiān)督管理局制定。

許可證的辦理條件

根據《醫(yī)療器械監(jiān)督管理條例》第三十一條的規(guī)定，從事第三類醫(yī)療器械業(yè)務的，經營企業(yè)應當向所在地設區(qū)的市級人民政府食品藥品監(jiān)督管理部門申請經營許可。

1.有與經營范圍相適應的營業(yè)場所和倉庫，并有特定的面積要求；

2.具有國家認可的專門從事產品經營的在職人員；

3、應有具有中專以上學歷的與產品管理相關的技術人員；

4.具有與所經營的醫(yī)療器械相適應的質量管理體系。

許可證的所需材料

pe of category III medical device license includes: medical electronic e, medical optical e, instruments and endoscopic e, medical magnetic resonance e, medical X-ray e, e and e in the operating room, emergency room and consulting room. According to the sale of medical devices must apply for the business license, the relevant national laws and regulations, the US Food and Drug Administration gradually implement the medical device management standardized management system. The management standards for medical devices are formulated by the United States Food and Drug Administration. Conditions for handling the permit According to Article 31 of the Regulations on the Supervision and Administration of Medical Devices, those engage