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：

1．《 醫療器械經(jīng)營(yíng)許可申請表》（原件1份）

2．《營(yíng)業(yè)執照》復印件（交驗原件）；（復印件1份）

3．法定代表人、企業(yè)負責人、質(zhì)量負責人的身份證明（查驗原件）、學(xué)歷或者職稱(chēng)證明復印件（對于統一采購渠道，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)量負責人身份證明、學(xué)歷或者職稱(chēng)證明復印件）；（交驗原件） （復印件共3份）

 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: The medical device business license is handled according to the Implementation Rules of Beijing Municipality (2017 Revision), and the specific materials are as follows: 1. Application Form for Business License of Medical Device (1 original) 2. Copy of Business License (original copy for inspection); (1 copy) 3. The legal representative, head of the enterprise, head of the certificate (check the original), certificate or title certificate copy (for unified purchasing channels, take the chain enterprise head certificate, certificate or copy of the title