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)模相適應的質(zhì)量管理機構或者質(zhì)量管理人員，質(zhì)量管理人員應當具有相關專 業(yè)學歷或者職稱；

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)療器械相適應的專 業(yè)指導、技術培訓和售后服務的質(zhì)量管理機構或者人員；

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)量負責人，其它人員身份證原件、復印件；
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、實地核查前會安排專人給相關人員培訓；
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)場驗收，驗收時需要提供人員的證明材料，驗收時人員本人必須在場。

鼎立信財稅公司專注服務佛山企業(yè)，十一年行業(yè)經(jīng)驗，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;">