1.具有與經(jīng)營(yíng)規模和經(jīng)營(yíng)范圍相適應的質(zhì)量管理機構或者專(zhuān)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(guān)專(zhuān)業(yè)學(xué)歷或者職稱(chēng)；

2.具有與經(jīng)營(yíng)規模和經(jīng)營(yíng)范圍相適應的相對獨立的經(jīng)營(yíng)場(chǎng)所；

3.具有與經(jīng)營(yíng)規模和經(jīng)營(yíng)范圍相適應的儲存條件，包括具有符合醫療器械產(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(jìn)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(yíng)的醫療器械產(chǎn)品相適應的技術(shù)培訓和售后服務(wù)的能力，或者約定由第三方提供技術(shù)支持；

6.經(jīng)營(yíng)無(wú)菌和植入類(lèi)產(chǎn)品的公司需建立計算機管理系統及計算機管理制度，能夠保證產(chǎn)品從購進(jìn)到銷(xiāo)售整個(gè)過(guò)程的有效質(zhì)量跟蹤和追溯。

申請醫療器械經(jīng)營(yíng)許可證所需材料：

醫療器械經(jīng)營(yíng)許可證辦理依據《北京市實(shí)施細則（2017年修訂版）》，具體提交材料如下：

ent institution or full-time management personnel suitable for the business scale and business scope. The management personnel shall have the relevant professional academic or professional titles recognized by the state; 2. Having a relatively independent business site commensurate with the scale and scope of business; 3. Having storage conditions suitable with the scale and scope of business, including storage facilities and e that meet the re of the characteristics of medical device products; 4. The product management system shall be established and improved, including procurement, purchase acceptance, storage, warehouse delivery review, tracking and adve