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: | 2023-11-24 18:26 |
最后更新: | 2023-11-24 18:26 |
瀏覽次數(shù): | 110 |
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1.有與經(jīng)營范圍相適應(yīng)的營業(yè)場所和倉庫,并有特定的面積要求;
2.具有國家認(rèn)可的專門從事產(chǎn)品經(jīng)營的在職人員;
3、應(yīng)有具有中專以上學(xué)歷的與產(chǎn)品管理相關(guān)的技術(shù)人員;
4.具有與所經(jīng)營的醫(yī)療器械相適應(yīng)的質(zhì)量管理體系。
許可證的所需材料
1.營業(yè)執(zhí)照;
2.企業(yè)負(fù)責(zé)人、質(zhì)量檢驗(yàn)人員和技術(shù)人員的身份、學(xué)歷和職稱證明;
3.營業(yè)場所證明和地理位置圖。
辦理后的注意事項(xiàng)
1.醫(yī)療器械經(jīng)營許可證的有效期只有5年。有效期需要延長的,醫(yī)療器械經(jīng)營企業(yè)應(yīng)當(dāng)在有效期屆滿前6個(gè)月向原發(fā)證部門申請(qǐng)延期《醫(yī)療器械經(jīng)營許可證》;
2.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),確保產(chǎn)品的可追溯性;
gement; 3. There should be technical personnel related to product management with a technical secondary school education or above; 4. Have a management system suitable for the medical devices it operates. Materials required for the permit 1. Business license; 2. The identity, educational background and professional title certificate of the person in charge of the enterprise, the inspection personnel and the technical personnel; 3. Business site certificate and geographical location map. Matters needing attention after handling 1. The validity period of the medical device business license is only 5 years. If the period of validity needs to be extended, the medical device trading enterprise shall