✅所需材料：

1️⃣医疗器械经营许可证申请表（包括基本信息、经营范围、经营期限等）。

2️⃣企业身份证明材料（营业执照、组织机构代码证、税务登记证等）。

3️⃣医疗器械相关证明材料（生产许可证、注册证、注册登记表等）。

4️⃣质量管理体系文件（质量手册、程序文件、操作规程等）。

5️⃣销售人员培训、考核、上岗证等证明材料。

6️⃣经营场所证明材料（租赁合同或购房合同、房产证等）。

7️⃣设备清单、购置发票等证明材料。

8️⃣企业承诺书（承诺所提供的材料真实有效，并承担法律责任）。

How long does it take to approve the registration of the class III medical device license? (1) Acceptance: The applicant shall apply to the Administrative Acceptance Service Center, submit the application materials in accordance with the catalogue listed in Article 6 of the Instructions, and the staff of the Acceptance Center shall examine the application materials in accordance with the requirements of the Acceptance Standards for the Registration and Application Materials of Domestic Third Class and Overseas Medical Devices (National Drug Administration [2005] No.111). Where the application item does not need to obtain an administrative license according to law, The applicant shall be informed immediately of the non-acceptance of the application; Where the application items do not fall within the scope of the functions and powers of the administrative organ according to law, A decision shall be made immediately, And inform the applicant to apply to the relevant administrative organ;