在我國經(jīng)營(yíng)銷(xiāo)售醫療器械必須取得相關(guān)資質(zhì)，那么北京地區三類(lèi)醫療器械經(jīng)營(yíng)許可證如何辦理，今天我們一起學(xué)習一下吧！

經(jīng)營(yíng)范圍包括哪些？

第三類(lèi)醫療器械許可的經(jīng)營(yíng)范圍包括：醫用電子設備、醫用光學(xué)設備、儀器和內鏡設備、醫用磁共振設備、醫用X射線(xiàn)設備、手術(shù)室、急診室和診室的設備和器具。根據售賣(mài)醫療器械必須辦理經(jīng)營(yíng)許可證，,國家相關(guān)法律法規，美國食品藥品監督管理局逐步推行醫療器械管理質(zhì)量標準化管理體系。醫療器械經(jīng)營(yíng)質(zhì)量管理規范由國家美國食品藥品監督管理局制定。

許可證的辦理條件

根據《醫療器械監督管理條例》第三十一條的規定，從事第三類(lèi)醫療器械業(yè)務(wù)的，經(jīng)營(yíng)企業(yè)應當向所在地設區的市級人民政府食品藥品監督管理部門(mén)申請經(jīng)營(yíng)許可。

1.有與經(jīng)營(yíng)范圍相適應的營(yíng)業(yè)場(chǎng)所和倉庫，并有特定的面積要求；

ment, 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 engaged in the business of ca