現場(chǎng)審核：申請材料提交后，醫療器械監督管理部門(mén)將對企業(yè)進(jìn)行現場(chǎng)審核，包括場(chǎng)地、人員、質(zhì)量管理、醫療器械采購、銷(xiāo)售等方面的審核。

預審：現場(chǎng)審核合格后，醫療器械監督管理部門(mén)將對申請材料進(jìn)行預審。

審核：預審合格后，醫療器械監督管理部門(mén)將進(jìn)行審核，審核包括企業(yè)的組織架構、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，醫療器械監督管理部門(mén)將頒發(fā)醫療器械經(jīng)營(yíng)許可證。

申請三類(lèi)醫療器械經(jīng)營(yíng)許可證需要滿(mǎn)足相關(guān)的資質(zhì)要求和管理要求，申請過(guò)程比較復雜，建議企業(yè)在申請前了解相關(guān)政策法規，以及咨詢(xún)專(zhuān)業(yè)的醫療器械代辦公司或律師事務(wù)所，提高申請成功率

隨著(zhù)相關(guān)制度的逐步完善，市場(chǎng)環(huán)境的逐漸向好，醫療器械或將迎來(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