公司注冊：需要進行公司注冊，注冊時應將公司的經營范圍與醫(yī)療器械經營范圍相符，并具備相應的注冊資金、地址、人員等條件。

設立醫(yī)療器械經營部門：在公司內設立專門的醫(yī)療器械經營部門，負責醫(yī)療器械的采購、銷售、倉儲和售后服務等工作。

聘請專業(yè)人員：聘請具有相關醫(yī)療器械經營經驗的專業(yè)人員，如負責人、注冊人員、經營管理人員、技術人員等。

提交申請材料：提交申請材料包括醫(yī)療器械經營許可證申請表、醫(yī)療器械經營許可證頒發(fā)范圍的說明、公司營業(yè)執(zhí)照、組織機構代碼證、稅務登記證、法人代表身份證、醫(yī)療器械經營負責人和技術人員的聘書、企業(yè)的藥品經營質量管理規(guī)范制度及其實施情況、醫(yī)療器械的采購渠道、銷售情況等。

現(xiàn)場審核：申請材料提交后，醫(yī)療器械監(jiān)督管理部門將對企業(yè)進行現(xiàn)場審核，包括場地、人員、質量管理、醫(yī)療器械采購、銷售等方面的審核。

預審：現(xiàn)場審核合格后，醫(yī)療器械監(jiān)督管理部門將對申請材料進行預審。

審核：預審合格后，醫(yī)療器械監(jiān)督管理部門將進行審核，審核包括企業(yè)的組織架構、質量管理體系、產品銷售情況等方面。

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