inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">醫(yī)療器械許可+備案
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">資料與流程（有需要的建議收藏）
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">一類醫(yī)療器械：不需要許可和備案
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">二類醫(yī)療器械：需要備案管理
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">三類醫(yī)療器械：需要許可和備案
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">接下來分享一下二類醫(yī)療器械備案的注意事項！
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">【二類醫(yī)療器械備案】：
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">定義：是需要對其安全性、有效性應(yīng)當(dāng)加以控制的醫(yī)療器械。
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">比如體溫計、血壓計、心電圖儀、霧化器等。
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">申請材料：
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?醫(yī)療器械備案申請書；
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?營業(yè)執(zhí)照正副本和公章；
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?法定代表人、質(zhì)量負(fù)責(zé)人的身份證明、學(xué)歷或者職稱證明復(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);">4?經(jīng)營場所、庫房圍地址的地理位置圖、平面圖、房屋產(chǎn)權(quán)證明文件或者租賃協(xié)議（商用性質(zhì)辦公80平，倉儲60平以上)；
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?產(chǎn)品經(jīng)營目錄表，合格證書：
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?商家購銷合同、進(jìn)貨渠道。
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">【申請流程】：
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?經(jīng)營企業(yè)應(yīng)當(dāng)向所在地設(shè)區(qū)的市級負(fù)責(zé)藥品監(jiān)督管理的部門提出申請。
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?申請材料不齊全或者不符合形式審查要求的，應(yīng)當(dāng)當(dāng)場或者在5個工作日內(nèi)發(fā)給申請人《補正材料通知書》，一次性告知申請人需要補正的全部內(nèi)容，逾期不告知的，自收到申請材料之日起即為受理。
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?申請材料齊全、符合形式審查要求的，或者申請人按照要求提交全部補正申請材料的，予以受理。
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">【辦理時間】:
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">資料符合要求，辦結(jié)時限20個工作日左右。
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">ps：醫(yī)療器械資質(zhì)辦理，對地址要求比較嚴(yán)格，可以找我提供地址哦。 精益求精集團(tuán)，專注醫(yī)藥資質(zhì)13年，將竭力為各醫(yī)療器械企業(yè)提供全面服務(wù)，幫各企業(yè)安全快速辦理各類醫(yī)療器械資質(zhì)，精益求精集團(tuán)積累了大量的港粵地區(qū)客戶的成功案例，在業(yè)界享有聲譽!精益求精集團(tuán)將傾力為企業(yè)提供一站式的服務(wù)，堅持“熱情服務(wù)，信譽至上“的宗旨，我們承諾:遵守職業(yè)道德，保守客戶機(jī)密。為客戶提供優(yōu)質(zhì)、熱情、周到的服務(wù)?。。?/span>