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(lèi)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)療器械代辦公司或律師事務(wù)所，提高申請(qǐng)成功率

隨著相關(guān)制度的逐步完善，市場(chǎng)環(huán)境的逐漸向好，醫(yī)療器械或?qū)⒂瓉?lái)噴涌爆發(fā)式的發(fā)展。

s are submitted, the medical device supervision and administration department will conduct on-site audit of the enterprise, including site, personnel, management, medical device procurement and sales. Pre-examination: After passing the on-site examination, the medical device supervision and administration department will conduct pre-examination of the application materials. Audit: After the pre-examination, the medical 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 a