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房山閻村北京醫(yī)療器械三類(lèi)經(jīng)營(yíng)許可證,醫(yī)療器械二類(lèi)備案提供進(jìn)銷(xiāo)存軟件人員專(zhuān)業(yè)快捷包下證,

醫(yī)療器械三類(lèi): 注冊(cè)
醫(yī)療器械二類(lèi): 注冊(cè)
注冊(cè)公司: 網(wǎng)絡(luò)銷(xiāo)售備案
單價(jià): 面議
發(fā)貨期限: 自買(mǎi)家付款之日起 天內(nèi)發(fā)貨
所在地: 直轄市 北京 北京海淀
有效期至: 長(zhǎng)期有效
發(fā)布時(shí)間: 2023-11-25 06:01
最后更新: 2023-11-25 06:01
瀏覽次數(shù): 141
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二、第三類(lèi)醫(yī)療器械經(jīng)營(yíng)許可證辦理流程:

1、經(jīng)營(yíng)企業(yè)經(jīng)辦人攜帶上述資料前往監(jiān)督管理部門(mén)申請(qǐng)經(jīng)營(yíng)許可;

2、工作人員受理資料,并于30個(gè)工作日內(nèi)進(jìn)行審查,必要時(shí)組織核查;

3、對(duì)符合規(guī)定條件的,準(zhǔn)予許可并發(fā)給醫(yī)療器械經(jīng)營(yíng)許可證;對(duì)不符合規(guī)定條件的,不予許可并書(shū)面說(shuō)明理由。

三、第三類(lèi)醫(yī)療器械經(jīng)營(yíng)許可證辦理所需材料:

1、企業(yè)名稱(chēng)與經(jīng)營(yíng)范圍,注冊(cè)資本及股東出資比例,股東等sfz明;

2、醫(yī)療器械產(chǎn)品注冊(cè)證書(shū)、供應(yīng)商營(yíng)業(yè)執(zhí)照、許可證及授權(quán)書(shū);

3、質(zhì)量管理文件等;

4、2個(gè)或以上醫(yī)學(xué)專(zhuān)業(yè)或相關(guān)專(zhuān)業(yè)人員證書(shū)、sfz明與簡(jiǎn)歷;

5、符合醫(yī)療器械經(jīng)營(yíng)要求的辦公場(chǎng)地及倉(cāng)庫(kù)證明;

6、公司章程、股東會(huì)決議等;

to the supervision and administration department for the business license with the above information; 2. The staff shall accept the materials, and review them within 30 working days, and organize the verification if necessary; 3. Grant license and medical device operation license for those who meet the prescribed conditions, and give reasons in writing. 3. Materials required for handling the business license of Class III medical devices: 1, the enterprise name and business scope, the registered capital and the proportion of shareholder contribution, shareholders and other sfz Ming; 2. Medical device product registration certificate, supplier business license, license and authorization letter; 3. management documents, etc.; 4,2 or more medical professional or related professional certificates, sfz Ming and resume; 5. Office space and war


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