聘請(qǐng)專業(yè)人員：聘請(qǐng)具有相關(guān)醫(yī)療器械經(jīng)營(yíng)經(jīng)驗(yàn)的專業(yè)人員，如負(fù)責(zé)人、注冊(cè)人員、經(jīng)營(yíng)管理人員、技術(shù)人員等。

提交申請(qǐng)材料：提交申請(qǐng)材料包括醫(yī)療器械經(jīng)營(yíng)許可證申請(qǐng)表、醫(yī)療器械經(jīng)營(yíng)許可證頒發(fā)范圍的說(shuō)明、公司營(yíng)業(yè)執(zhí)照、組織機(jī)構(gòu)代碼證、稅務(wù)登記證、法人代表身份證、醫(yī)療器械經(jīng)營(yíng)負(fù)責(zé)人和技術(shù)人員的聘書(shū)、企業(yè)的藥品經(jīng)營(yíng)質(zhì)量管理規(guī)范制度及其實(shí)施情況、醫(yī)療器械的采購(gòu)渠道、銷(xiāo)售情況等。

現(xiàn)場(chǎng)審核：申請(qǐng)材料提交后，醫(yī)療器械監(jiān)督管理部門(mén)將對(duì)企業(yè)進(jìn)行現(xiàn)場(chǎng)審核，包括場(chǎng)地、人員、質(zhì)量管理、醫(yī)療器械采購(gòu)、銷(xiāo)售等方面的審核。

預(yù)審：現(xiàn)場(chǎng)審核合格后，醫(yī)療器械監(jiān)督管理部門(mén)將對(duì)申請(qǐng)材料進(jìn)行預(yù)審。

審核：預(yù)審合格后，醫(yī)療器械監(jiān)督管理部門(mén)將進(jìn)行審核，審核包括企業(yè)的組織架構(gòu)、質(zhì)量管理體系、產(chǎn)品銷(xiāo)售情況等方面。

頒發(fā)許可證：審核通過(guò)后，醫(yī)療器械監(jiān)督管理部門(mén)將頒發(fā)醫(yī)療器械經(jīng)營(yíng)許可證。

申請(qǐng)三類醫(yī)療器械經(jīng)營(yíng)許可證需要滿足相關(guān)的資質(zhì)要求和管理要求，申請(qǐng)過(guò)程比較復(fù)雜，建議企業(yè)在申請(qǐng)前了解相關(guān)政策法規(guī)，以及咨詢專業(yè)的醫(yī)療器械代辦公

device supervision and management department will conduct an audit, including the organizational structure, management system, product sales, etc. License issuance: After the approval, the medical device supervision and administration department will issue the medical device business license. The application for the business license of Class III medical devices needs to meet the relevant re and management re, and the application process is quite complicated. It is suggested that enterprises understand the relevant policies and regulations before applying, as well as consulting professional medical devices