北京第二类医疗器械经营备案人员要求：

批发：第二类医疗器械（不含体外诊断试剂）

质量负责人应具有（医疗器械、机械、电子、生物、化学、医学、药学、化工、计算机）的专业学历，大专以上学历或初级以上技术职称。

批发：第二类医疗器械（不含体外诊断试剂）

经营使用面积（㎡) ≥30㎡，库房使用面积（㎡) ≥15㎡；

北京二类医疗器械备案需要的资料：

1、第二类医疗器械经营备案申请表

2、营业执照和组织机构代码证复印件；

3、法定代表人、企业负责人、质量负责人的身份证明、学历或者职称证明复印件；

4、组织机构与部门设置说明；

5、经营范围、经营方式说明

6、经营场所、库房地址的地理位置图、平面图、房屋产权证明文件或者租赁协议（附房屋产权证明文件）复印件；

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;