以上就是辦理醫(yī)療器械許可證需要的資料流程和下證時間，您還需提供以下材料：1、企業(yè)名稱與經(jīng)營范圍，注冊資本及股東出資比例，股東等身份證明；2、醫(yī)療器械產(chǎn)品注冊證書、供應商營業(yè)執(zhí)照、許可證及授權書；3、質量管理文件等;4、2個或以上醫(yī)學專業(yè)或相關專業(yè)人員證書、身份證明與簡歷；5、符合醫(yī)療器械經(jīng)營要求的辦公場地及倉庫證明； 6、公司章程、股東會決議等；7、財務人員身份證和上崗證。

三類醫(yī)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、境外醫(yī)療器械注冊申報資料受理標 準》(國藥監(jiān)械[2005]111號) 的要求對申請材料進行形式審查。申請事項依法不需要取得行政許可的，應當即時告知申請人不受理;申請事項依法不屬 于本行政機關職權范圍的，應當即時作出不 予受理的決定，并告知申請人向有關行政

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