二、第三類醫(yī)"/>
醫(yī)療器械三類: | 注冊 |
醫(yī)療器械二類: | 注冊 |
注冊公司: | 網(wǎng)絡(luò)銷售備案 |
單價(jià): | 面議 |
發(fā)貨期限: | 自買家付款之日起 天內(nèi)發(fā)貨 |
所在地: | 直轄市 北京 北京海淀 |
有效期至: | 長期有效 |
發(fā)布時(shí)間: | 2023-11-24 19:21 |
最后更新: | 2023-11-24 19:21 |
瀏覽次數(shù): | 90 |
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(2)相關(guān)部門受理申請人的申請;
(3)到實(shí)際場地進(jìn)行勘察以及對產(chǎn)品進(jìn)行審核;
(4)準(zhǔn)予頒發(fā)三類醫(yī)療器械許可證。
二、第三類醫(yī)療器械經(jīng)營許可證辦理流程:
1、經(jīng)營企業(yè)經(jīng)辦人攜帶上述資料前往監(jiān)督管理部門申請經(jīng)營許可;
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)營許可證;對不符合規(guī)定條件的,不予許可并書面說明理由。
三、第三類醫(yī)療器械經(jīng)營許可證辦理所需材料:
1、企業(yè)名稱與經(jīng)營范圍,注冊資本及股東出資比例,股東等sfz明;
2、醫(yī)療器械產(chǎn)品注冊證書、供應(yīng)商營業(yè)執(zhí)照、許可證及授權(quán)書;
3、質(zhì)量管理文件等;
4、2個(gè)或以上醫(yī)學(xué)專業(yè)或相關(guān)專業(yè)人員證書、sfz明與簡歷;
application of the applicant; (3) Investigate the actual site and audit the products; (4) Grant the issuance of a class III medical device license. 2. Process for handling the business license of Class III Medical Devices: 1. The operator of the operating enterprise shall bring the above information to the supervision and administration department to apply for the business license; 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