2.具有與經(jīng)營規(guī)模和經(jīng)營范圍相適應(yīng)的相對(duì)獨(dú)立的經(jīng)營場(chǎng)所；

3.具有與經(jīng)營規(guī)模和經(jīng)營范圍相適應(yīng)的儲(chǔ)存條件，包括具有符合醫(yī)療器械產(chǎn)品特性要求的儲(chǔ)存設(shè)施,、設(shè)備；

4.應(yīng)當(dāng)建立健全產(chǎn)品質(zhì)量管理制度，包括采購、進(jìn)貨驗(yàn)收,、倉儲(chǔ)保管、出庫復(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)營無菌和植入類產(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)品從購進(jìn)到銷售整個(gè)過程的有效質(zhì)量跟蹤和追溯。

申請(qǐng)醫(yī)療器械經(jīng)營許可證所需材料：

醫(yī)療器械經(jīng)營許可證辦理依據(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)營許可申請(qǐng)表》（原件1份）

2．《營業(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)歷或者職稱證明復(fù)印件（對(duì)于統(tǒng)一采購渠道，采取連鎖經(jīng)營的非法人零售企業(yè),，提供連鎖企業(yè)總部質(zhì)量負(fù)責(zé)人身份證明,、學(xué)歷或者職稱證明復(fù)印件）；（交驗(yàn)原件） （復(fù)印件共3份）

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 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 steril