醫(yī)療器械三類: | 注冊(cè) |
醫(yī)療器械二類: | 注冊(cè) |
注冊(cè)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: | 2023-11-25 04:56 |
最后更新: | 2023-11-25 04:56 |
瀏覽次數(shù): | 91 |
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其次,經(jīng)營企業(yè)要知曉辦理三類醫(yī)療器械經(jīng)營許可證需要準(zhǔn)備哪些資料。
(1)提交醫(yī)療器械經(jīng)營企業(yè)許可證申請(qǐng)表,法定代表人簽字或加蓋企業(yè)公章;
(2)工商行政管理部門出具的企業(yè)名稱預(yù)核準(zhǔn)證明文件或《營業(yè)執(zhí)照》復(fù)印件和校驗(yàn)原件;
(3)企業(yè)質(zhì)量管理負(fù)責(zé)人的身份證、學(xué)歷或者職稱證明復(fù)印件及個(gè)人簡(jiǎn)歷;質(zhì)量管理人員的身份證、學(xué)歷或者職稱證明復(fù)印件;
(4)經(jīng)營場(chǎng)所、倉庫的地理位置圖、平面圖(注明面積)、房屋產(chǎn)權(quán)證明或者租賃協(xié)議復(fù)印件;
(5)企業(yè)產(chǎn)品質(zhì)量管理制度文件及儲(chǔ)存設(shè)施、設(shè)備目錄。
(6)對(duì)于辦理三類醫(yī)療器械經(jīng)營許可證內(nèi)容包含有需要冷藏的藥品時(shí),企業(yè)具備的運(yùn)輸裝備、倉儲(chǔ)設(shè)施設(shè)備情況表。
、第三類醫(yī)療器械經(jīng)營許可證怎么辦理
(1)申請(qǐng)人提交申請(qǐng)資料到相關(guān)部門;
ate of the enterprise name or the Business License issued by the administrative department for industry and commerce; (3) A copy of the id card, educational background or professional title certificate and personal resume of the management manager of the enterprise; a copy of the id card, educational background or professional title certificate of the management personnel; (4) The map of the geographical location, the plan (indicating the area), the property right certificate or the copy of the lease agreement; (5) Enterprise product management system documents and catalogue of storage facilities and e (6) Table of transportation e and storage facilities and e available by the enterprise when the contents of the business license contains drugs that need to b