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(lèi)醫療器械：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(lèi)醫療器械：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(lèi)醫療器械：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(lái)分享一下二類(lèi)醫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(lèi)醫療器械備案】：
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、有效性應當加以控制的醫療器械。
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?醫療器械備案申請書(shū)；
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(yíng)業(yè)執照正副本和公章；
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)量負責人的身份證明、學(xué)歷或者職稱(chēng)證明復印件；
inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">4?經(jīng)營(yíng)場(chǎng)所、庫房圍地址的地理位置圖、平面圖、房屋產(chǎn)權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(yíng)目錄表，合格證書(shū)：
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(xiāo)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(yíng)企業(yè)應當向所在地設區的市級負責藥品監督管理的部門(mén)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，應當當場(chǎng)或者在5個(gè)工作日內發(fā)給申請人《補正材料通知書(shū)》，一次性告知申請人需要補正的全部?jì)热?，逾期不告知的，自收到申請材料之日起即為受理?/span>
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(shí)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，辦結時(shí)限20個(gè)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：醫療器械資質(zhì)辦理，對地址要求比較嚴格，可以找我提供地址哦。 精益求精集團，專(zhuān)注醫藥資質(zhì)13年，將竭力為各醫療器械企業(yè)提供全面服務(wù)，幫各企業(yè)安全快速辦理各類(lèi)醫療器械資質(zhì)，精益求精集團積累了大量的港粵地區客戶(hù)的成功案例，在業(yè)界享有聲譽(yù)!精益求精集團將傾力為企業(yè)提供一站式的服務(wù)，堅持“熱情服務(wù)，信譽(yù)至上“的宗旨，我們承諾:遵守職業(yè)道德，保守客戶(hù)機密。為客戶(hù)提供優(yōu)質(zhì)、熱情、周到的服務(wù)?。?！