3．法定代表人、企業負責人、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（對于統一采購渠道，采取連鎖經營的非法人零售企業，提供連鎖企業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）

4．企業基本情況（原件1份）。（內容包含：組織機構與部門設置說明、經營場所、庫房的地理位置圖、平面圖（注明面積）、庫房的產權證明及使用權證明復印件、（委托貯存的，應提交經營場所地理位置圖、平面圖（注明面積）和與被委托方簽署的書面協議復印件、被委托方的《醫療器械經營許可證》復印件）

5.企業設施設備情況（原件1份）。（內容包含：經營設施、設備目錄、經營質量管理制度、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明）（原件1份）

se, of the identity certificate (check the original), certificate or title certificate copy (for unified purchasing channels, take the chain enterprise head identity certificate, degree or copy of the title certificate); (submit the original) (copy of 3 copies) 4. Basic information of the enterprise (1 original copy).(Content includes: organization and department set instructions, 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) and the written agreement signed with the principal, the principal copy of the medical device business license) 5. Enterprise facilities and e information (1 original copy).(Contents include: business facilities, e catalo