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

三類(lèi)醫(yī)療器械經(jīng)營(yíng)許可證辦理所需大致資料:

1、企業(yè)經(jīng)營(yíng)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(yíng)場(chǎng)所證明以及地理位置圖。

三類(lèi)醫(yī)療器械經(jīng)營(yíng)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(yíng)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(yíng)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(mén)提出《醫(yī)療器械經(jīng)營(yíng)許可證》延續(xù)申請(qǐng)。

2、應(yīng)當(dāng)具有符合醫(yī)療器械經(jīng)營(yíng)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(yíng)產(chǎn)品的可追溯。

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

4、自行停業(yè)一年以上，重新經(jīng)營(yíng)時(shí)，應(yīng)當(dāng)提前書(shū)面報(bào)告所在地設(shè)區(qū)的市級(jí)食品藥品監(jiān)督管理部門(mén)，經(jīng)核查符合要求后方可恢復(fù)經(jīng)營(yíng)。

implemented the standard management system of medical device business. The management standards for medical devices shall be formulated by the State Food and Drug Administration. General information required for handling the business license of Class III medical devices: 1. Business license; 2. Certificate of identity, educational background and professional title of the person in charge of the enterprise, inspection personnel and technical personnel; 3. Certificate of business site and geographical location map. Several matters needing attention should be clarified after