以上就是辦理醫療器械許可證需要的資料流程和下證時(shí)間，您還需提供以下材料：1、企業(yè)名稱(chēng)與經(jīng)營(yíng)范圍，注冊資本及股東出資比例，股東等身份證明；2、醫療器械產(chǎn)品注冊證書(shū)、供應商營(yíng)業(yè)執照、許可證及授權書(shū)；3、質(zhì)量管理文件等;4、2個(gè)或以上醫學(xué)專(zhuān)業(yè)或相關(guān)專(zhuān)業(yè)人員證書(shū)、身份證明與簡(jiǎn)歷；5、符合醫療器械經(jīng)營(yíng)要求的辦公場(chǎng)地及倉庫證明； 6、公司章程、股東會(huì )決議等；7、財務(wù)人員身份證和上崗證。

三類(lèi)醫療器械許可證注冊審批大致需要多久？

（一）受理：

申請人向行政受理服務(wù)中心提出申請，按照本《須知》第六條所列目錄提交申請材料，受理中心工作人員按照《境內第三類(lèi)、境外醫療器械注冊申報資料受理標 準》(國藥監械[2005]111號) 的要求對申請材料進(jìn)行形式審查。申請事項依法不需要取得行政許可的，應當即時(shí)告知申請人不受理;申請事項依法不屬 于本行政機關(guān)職權范圍的，應當即時(shí)作出不 予受理的決定，并告知申請人向有關(guān)行政

e Service Center, submit the application materials in accordance with the catalogue listed in Article 6 of the Instructions, and the staff of the Acceptance Center shall examine the application materials in accordance with the re of the Acceptance Standards for the Registration and Application Materials of Domestic Third Class and Overseas Medical Devices (National Drug Administration [2005] No.111). If the application items do not need to obtain the administrative license according to the law, the applicant shall be immediately informed that the applicant does not accept the application; if the application items do not fall within the scope of functions and powers of the administrative organ, it shall be immediately rejected and inform the applicant to inform the relevant administration