北京平谷区流程医疗器械三类经营许可证，医疗器械二类备案办理提供软件诚信经营

✅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）。

1. What is a medical device? Beijing wants to understand the enterprises to see here Medical device: refers to instruments, equipment, appliances, materials or other articles used individually or in combination, including required software; their function on the surface of the body is not obtained by pharmacological, immunology or metabolic means, but may participate and play a certain auxiliary role. 2. How many categories are medical devices divided into? There are three categories: The operation of the first type of medical devices does