北京平谷区材料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liangdacongyou

1.需要办理许可证的企业经营者携带上述材料到当地市级人民政府食品监督管理部门申请营业执照； 
2.管理部门受理资料，30个工作日内审核，必要时组织审核； 
3.符合条件的，管理部门发行医疗器械经验许可证，不符合条件的，管理部门不予许可，书面说明理由。 

办理医疗器械经营许可证需要满足以下要求： 
1、含有植入材料介入器材的质量负责人当具有医学相关大专以上学历，三年以上工作经验; 2、含有体外试剂的有1人为主管检验师，具有本科以上学历并检验学;有1人为质量管理人，大z以上学历或者中级以上技术职称; 

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;