inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">哪些企業(yè)需要辦理二類醫(yī)療器械備案？凡是從事第二類醫(yī)療器械經(jīng)營的企業(yè),，需要辦理醫(yī)療器械經(jīng)營備案,。inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap;">那么，二類醫(yī)療器械備案辦理需要哪些條件呢,？

inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255); font-size: 18px;">一,、具有與經(jīng)營范圍和經(jīng)營規(guī)模相適應(yīng)的質(zhì)量管理機(jī)構(gòu)或者質(zhì)量管理人員,，質(zhì)量管理人員應(yīng)當(dāng)具有相關(guān)專 業(yè)學(xué)歷或者職稱；

inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255); font-size: 18px;">二,、具有與經(jīng)營范圍和經(jīng)營規(guī)模相適應(yīng)的經(jīng)營場所,；

inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255); font-size: 18px;">三、具有與經(jīng)營范圍和經(jīng)營規(guī)模相適應(yīng)的貯存條件,；

inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255); font-size: 18px;">四,、具有與經(jīng)營的醫(yī)療器械相適應(yīng)的質(zhì)量管理制度；

inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255); font-size: 18px;">五,、具有與經(jīng)營的醫(yī)療器械相適應(yīng)的專 業(yè)指導(dǎo),、技術(shù)培訓(xùn)和售后服務(wù)的質(zhì)量管理機(jī)構(gòu)或者人員；

inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">第二類醫(yī)療器械經(jīng)營備案辦理所需資料：

inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">1,、公司營業(yè)執(zhí)照,；
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">2、公司法定代表人身份證復(fù)印件,；
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">3,、互聯(lián)網(wǎng)藥品信息服務(wù)許可證原件；
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">4,、質(zhì)量負(fù)責(zé)人,，其它人員身份證原件、復(fù)印件,；
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">5,、增值電信業(yè)務(wù)經(jīng)營許可證（ICP、域名備案文件或EDI）,；
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">6,、實(shí)地核查前會(huì)安排專人給相關(guān)人員培訓(xùn)；
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">7,、現(xiàn)場驗(yàn)收,，驗(yàn)收時(shí)需要提供人員的證明材料，驗(yàn)收時(shí)人員本人必須在場,。

鼎立信財(cái)稅公司專注服務(wù)佛山企業(yè),，十一年行業(yè)經(jīng)驗(yàn)，歡迎咨詢哦~

inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255); font-size: 18px;">