隨著國民經(jīng)濟的穩(wěn)步發(fā)展和人們對醫(yī)療健康的廣泛關(guān)注，醫(yī)療行業(yè)成為眾多投資伙伴關(guān)注的焦點。想要涉足醫(yī)療器械領(lǐng)域，這些基礎(chǔ)知識是不能忽視的！

在我國經(jīng)營銷售醫(yī)療器械必須取得相關(guān)資質(zhì)，那么北京地區(qū)三類醫(yī)療器械經(jīng)營許可證如何辦理，今天我們一起學(xué)習(xí)一下吧！

經(jīng)營范圍包括哪些？

第三類醫(yī)療器械許可的經(jīng)營范圍包括：醫(yī)用電子設(shè)備、醫(yī)用光學(xué)設(shè)備、儀器和內(nèi)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、急診室和診室的設(shè)備和器具。根據(jù)售賣醫(yī)療器械必須辦理經(jīng)營許可證，,國家相關(guān)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(zhì)量標(biāo)準(zhǔn)化管理體系。醫(yī)療器械經(jīng)營質(zhì)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(jù)《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(wù)的，經(jīng)營企業(yè)應(yīng)當(dāng)向所在地設(shè)區(qū)的市級人民政府食品藥品監(jiān)督管理部門申請經(jīng)營許可。

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 category III medical devices shall apply for a business license to the food and drug regulatory department of the people's government of the city at the level divided into districts where it is located.