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）

4．企業(yè)基本情況（原件1份）。（內容包含：組織機構與部門(mén)設置說(shuō)明、經(jīng)營(yíng)場(chǎng)所、庫房的地理位置圖、平面圖（注明面積）、庫房的產(chǎn)權證明及使用權證明復印件、（委托貯存的，應提交經(jīng)營(yíng)場(chǎng)所地理位置圖、平面圖（注明面積）和與被委托方簽署的書(shū)面協(xié)議復印件、被委托方的《醫療器械經(jīng)營(yíng)許可證》復印件）

5.企業(yè)設施設備情況（原件1份）。（內容包含：經(jīng)營(yíng)設施、設備目錄、經(jīng)營(yíng)質(zhì)量管理制度、工作程序等文件目錄、計算機信息管理系統基本情況介紹和功能說(shuō)明）（原件1份）

dled 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, of the identity certificate (check the original), certificate or title certificate copy (for unified purchasing channels, take the chain enterprise head identity certificate, head of the degree or title certificate copy); (submit the original) (copy of 3 copies) 4. Basic information of the enterprise (1 original copy).(Content includes: organization and department set, premises, warehouse location map, plan (indicate area), warehouse of property certificate and use right certificate copy, (entrust storage, should be submitted to the site location, plan (indicate area) a