二、第三類醫療器械經營許可證辦理流程：

1、經營企業經辦人攜帶上述資料前往監督管理部門申請經營許可；

2、工作人員受理資料，并于30個工作日內進行審查，必要時組織核查；

3、對符合規定條件的，準予許可并發給醫療器械經營許可證；對不符合規定條件的，不予許可并書面說明理由。

三、第三類醫療器械經營許可證辦理所需材料:

1、企業名稱與經營范圍，注冊資本及股東出資比例，股東等sfz明；

2、醫療器械產品注冊證書、供應商營業執照、許可證及授權書；

3、質量管理文件等；

4、2個或以上醫學專業或相關專業人員證書、sfz明與簡歷；

5、符合醫療器械經營要求的辦公場地及倉庫證明；

ess license of Class III Medical Devices: 1. The operator of the operating enterprise shall apply to the supervision and administration department for the business license with the above information; 2. The staff shall accept the materials, and review them within 30 working days, and organize the verification if necessary; 3. Grant license and medical device operation license for those who meet the prescribed conditions, and give reasons in writing. 3. Materials required for handling the business license of Class III medical devices: 1, the enterprise name and business scope, the registered capital and the proportion of shareholder contribution, shareholders and other sfz Ming; 2. Medical device product registrati