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(shí)間，您還需提供以下材料：1、企業(yè)名稱與經(jīng)營(yíng)范圍，注冊(cè)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(cè)證書、供應(yīng)商營(yíng)業(yè)執(zhí)照、許可證及授權(quán)書；3、質(zhì)量管理文件等;4、2個(gè)或以上醫(yī)學(xué)專業(yè)或相關(guān)專業(yè)人員證書、身份證明與簡(jiǎn)歷；5、符合醫(yī)療器械經(jīng)營(yíng)要求的辦公場(chǎng)地及倉(cāng)庫(kù)證明； 6、公司章程、股東會(huì)決議等；7、財(cái)務(wù)人員身份證和上崗證。

三類醫(yī)療器械許可證注冊(cè)審批大致需要多久？

（一）受理：

申請(qǐng)人向行政受理服務(wù)中心提出申請(qǐng)，按照本《須知》第六條所列目錄提交申請(qǐng)材料，受理中心工作人員按照《境內(nèi)第三類、境外醫(yī)療器械注冊(cè)申報(bào)資料受理標(biāo) 準(zhǔn)》(國(guó)藥監(jiān)械[2005]111號(hào)) 的要求對(duì)申請(qǐng)材料進(jìn)行形式審查。申請(qǐng)事項(xiàng)依法不需要取得行政許可的，應(yīng)當(dāng)即時(shí)告知申請(qǐng)人不受理;申請(qǐng)事項(xiàng)依法不屬 于本行政機(jī)關(guān)職權(quán)范圍的，應(yīng)當(dāng)即時(shí)作出不 予受理的決定，并告知申請(qǐng)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