1.具有與經(jīng)營(yíng)規(guī)模和經(jīng)營(yíng)范圍相適應(yīng)的質(zhì)量管理機(jī)構(gòu)或者專(zhuān)職質(zhì)量管理人員。質(zhì)量管理人員應(yīng)當(dāng)具有國(guó)家認(rèn)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(guī)模和經(jīng)營(yíng)范圍相適應(yīng)的相對(duì)獨(dú)立的經(jīng)營(yíng)場(chǎng)所；

3.具有與經(jīng)營(yíng)規(guī)模和經(jīng)營(yíng)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(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：

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