4.應(yīng)當(dāng)建立健全產(chǎn)品質(zhì)量管理制度，包括采購(gòu)、進(jìn)貨驗(yàn)收、倉(cāng)儲(chǔ)保管、出庫(kù)復(fù)核、質(zhì)量跟蹤和不良事件的報(bào)告制度等；

5.應(yīng)當(dāng)具有與其經(jīng)營(yíng)的醫(yī)療器械產(chǎn)品相適應(yīng)的技術(shù)培訓(xùn)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(jì)算機(jī)管理系統(tǒng)及計(jì)算機(jī)管理制度，能夠保證產(chǎn)品從購(gòu)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(qǐng)醫(yī)療器械經(jīng)營(yíng)許可證所需材料：

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

1．《 醫(yī)療器械經(jīng)營(yíng)許可申請(qǐng)表》（原件1份）

2．《營(yíng)業(yè)執(zhí)照》復(fù)印件（交驗(yàn)原件）；（復(fù)印件1份）

3．法定代表人、企業(yè)負(fù)責(zé)人、質(zhì)量負(fù)責(zé)人的身份證明（查驗(yàn)原件）、學(xué)歷或者職稱(chēng)證明復(fù)印件（對(duì)于統(tǒng)一采購(gòu)渠道，采取連鎖經(jīng)營(yíng)的非法人零售企業(yè)，提供連鎖企業(yè)總部質(zhì)量負(fù)責(zé)人身份證明、學(xué)歷或者職稱(chēng)證明復(fù)印件）；（交驗(yàn)原件） （復(fù)印件共3份）

 product management system shall be established and improved, including procurement, purchase acceptance, storage, warehouse delivery review, tracking and adverse event reporting system; 5. It shall have 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 Busine