三類申請醫(yī)療器械經(jīng)營許可證條件：

1.具有與經(jīng)營規(guī)模和經(jīng)營范圍相適應的質(zhì)量管理機構或者專職質(zhì)量管理人員,。質(zhì)量管理人員應當具有國家認可的相關專業(yè)學歷或者職稱,；

2.具有與經(jīng)營規(guī)模和經(jīng)營范圍相適應的相對獨立的經(jīng)營場所,；

3.具有與經(jīng)營規(guī)模和經(jīng)營范圍相適應的儲存條件,，包括具有符合醫(yī)療器械產(chǎn)品特性要求的儲存設施,、設備,；

4.應當建立健全產(chǎn)品質(zhì)量管理制度,，包括采購,、進貨驗收,、倉儲保管,、出庫復核、質(zhì)量跟蹤和不良事件的報告制度等,；

5.應當具有與其經(jīng)營的醫(yī)療器械產(chǎn)品相適應的技術培訓和售后服務的能力,，或者約定由第三方提供技術支持；

6.經(jīng)營無菌和植入類產(chǎn)品的公司需建立計算機管理系統(tǒng)及計算機管理制度,，能夠保證產(chǎn)品從購進到銷售整個過程的有效質(zhì)量跟蹤和追溯,。

申請醫(yī)療器械經(jīng)營許可證所需材料：

the ability of technical training and after-sales service suitable with the medical device products it operates, or agree to provide technical support by a third party; 6. Companies operating sterile and implanted products shall establish a computer management system and a computer management system to ensure the effective tracking and traceability of the whole process of products from purchase to sales. Materials required for applying for the Medical Device Business License: