三類醫(yī)療器械許可證經(jīng)營范圍包括:醫(yī)用電子儀器設(shè)備，醫(yī)用光學(xué)器具、儀器及內(nèi)窺鏡設(shè)備，醫(yī)用磁共振設(shè)備，醫(yī)用X射線設(shè)備，手術(shù)室、急救室、診療室設(shè)備及器具。售賣醫(yī)療器械必須辦理經(jīng)營許可

證，根據(jù)相關(guān)法律規(guī)定，國家食品藥品監(jiān)督管理局逐步推行醫(yī)療器械經(jīng)營質(zhì)量規(guī)范管理制度。醫(yī)療器械經(jīng)營質(zhì)量管理規(guī)范由國家食品藥品監(jiān)管管理局組織制定。

三類醫(yī)療器械經(jīng)營許可證辦理所需大致資料:

1、企業(yè)經(jīng)營執(zhí)照;2、企業(yè)負(fù)責(zé)人以及質(zhì)檢人員和技術(shù)人員的身份、學(xué)歷、職稱證明;3、經(jīng)營場所證明以及地理位置圖。

三類醫(yī)療器械經(jīng)營許可證辦理之后需要明確的幾個(gè)注意事項(xiàng)

1、醫(yī)療器械經(jīng)營許可證的有效期只有5年。有效期屆滿需要延續(xù)的，醫(yī)療器械經(jīng)營企業(yè)應(yīng)當(dāng)在有效期屆滿6個(gè)月前，向原發(fā)證部門提出《醫(yī)療器械經(jīng)營許可證》延續(xù)申請。

2、應(yīng)當(dāng)具有符合醫(yī)療器械經(jīng)營質(zhì)量管理要求的計(jì)算機(jī)信息管理系統(tǒng)，保證經(jīng)營產(chǎn)品的可追溯。

3、應(yīng)當(dāng)建立銷售記錄制度和建立質(zhì)量管理自查制度。

evice trading enterprise shall, 6 months prior to the expiration of the validity period, apply to the original department of validity. 2. It shall have a computer information management system that meets the re of business management of medical devices to ensure the traceability of business products. 3. A sales record system and a management self-inspection system shall be established.