2.具有與經(jīng)營規(guī)模和經(jīng)營范圍相適應的相對獨立的經(jīng)營場所,；

3.具有與經(jīng)營規(guī)模和經(jīng)營范圍相適應的儲存條件，包括具有符合醫(yī)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)品質量管理制度，包括采購,、進貨驗收,、倉儲保管、出庫復核,、質量跟蹤和不良事件的報告制度等,；

5.應當具有與其經(jīng)營的醫(yī)療器械產(chǎn)品相適應的技術培訓和售后服務的能力，或者約定由第三方提供技術支持,；

6.經(jīng)營無菌和植入類產(chǎn)品的公司需建立計算機管理系統(tǒng)及計算機管理制度,，能夠保證產(chǎn)品從購進到銷售整個過程的有效質量跟蹤和追溯。

申請醫(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)《北京市實施細則（2017年修訂版）》,，具體提交材料如下：

1．《 醫(yī)療器械經(jīng)營許可申請表》（原件1份）

2．《營業(yè)執(zhí)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,、質量負責人的身份證明（查驗原件）,、學歷或者職稱證明復印件（對于統(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)總部質量負責人身份證明,、學歷或者職稱證明復印件）；（交驗原件） （復印件共3份）

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 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 t