公司注冊(cè)：需要進(jìn)行公司注冊(cè)，注冊(cè)時(shí)應(yīng)將公司的經(jīng)營(yíng)范圍與醫(yī)療器械經(jīng)營(yíng)范圍相符，并具備相應(yīng)的注冊(cè)資金、地址、人員等條件。

設(shè)立醫(yī)療器械經(jīng)營(yíng)部門(mén)：在公司內(nèi)設(shè)立專(zhuān)門(mén)的醫(yī)療器械經(jīng)營(yíng)部門(mén)，負(fù)責(zé)醫(yī)療器械的采購(gòu)、銷(xiāo)售、倉(cāng)儲(chǔ)和售后服務(wù)等工作。

聘請(qǐng)專(zhuān)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(zhuān)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。

needs to be registered. When registration, the business scope of the company should be consistent with the business scope of medical devices, and the corresponding registered capital, address, personnel and other conditions should be met. Set up a medical device business department: set up a special medical device business department in the company to be responsible for the procurement, sales, storage and after-sales service of medical devices. Professionals: hire professionals with relevant medical device business experience, such as responsible person, registered personnel, management personnel, technical personnel, etc. Submit application materials: submit the application materials including medical device business license application form, the scope of medical device busi