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(xiāo)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(lèi)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(lèi)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(lèi)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。

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