提交申請材料：提交申請材料包括醫療器械經(jīng)營(yíng)許可證申請表、醫療器械經(jīng)營(yíng)許可證頒發(fā)范圍的說(shuō)明、公司營(yíng)業(yè)執照、組織機構代碼證、稅務(wù)登記證、法人代表身份證、醫療器械經(jīng)營(yíng)負責人和技術(shù)人員的聘書(shū)、企業(yè)的藥品經(jīng)營(yíng)質(zhì)量管理規范制度及其實(shí)施情況、醫療器械的采購渠道、銷(xiāo)售情況等。

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。

新政策要求：醫療器械經(jīng)營(yíng)企業(yè)要在經(jīng)營(yíng)活動(dòng)中積極應用唯一標識，做好帶碼入

lication materials including medical device business license application form, the scope of medical device business license, company business license, organization code certificate, tax registration certificate, legal representative id card, medical e management and appointment of technical personnel, the enterprise drug management management system and its implementation, medical e procurement channels, sales, etc. On-site audit: After the application materials 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