隨著國(guó)民經(jīng)濟(jì)的穩(wěn)步發(fā)展和人們對(duì)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(diǎn)。想要涉足醫(yī)療器械領(lǐng)域，這些基礎(chǔ)知識(shí)是不能忽視的！

在我國(guó)經(jīng)營(yíng)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(yíng)許可證如何辦理，今天我們一起學(xué)習(xí)一下吧！

經(jīng)營(yíng)范圍包括哪些？

第三類醫(yī)療器械許可的經(jīng)營(yíng)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(mài)醫(yī)療器械必須辦理經(jīng)營(yíng)許可證，,國(guó)家相關(guān)法律法規(guī)，美國(guó)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(yíng)質(zhì)量管理規(guī)范由國(guó)家美國(guó)食品藥品監(jiān)督管理局制定。

許可證的辦理?xiàng)l件

根據(jù)《醫(yī)療器械監(jiān)督管理?xiàng)l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(yíng)企業(yè)應(yīng)當(dāng)向所在地設(shè)區(qū)的市級(jí)人民政府食品藥品監(jiān)督管理部門(mén)申請(qǐng)經(jīng)營(yíng)許可。

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

 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 third class of medical device business shall apply for a business license to the food and drug supervisory and administrative department of the p