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库房放心省心

First of all, we must be clear about whatinformation is needed for the three types of business license ofmedical devices; 1. Company license principal and secondary copy 2.Official seal 3. Copy of the office and warehouse room 4. Personnel(mainly the quality manager and the competent inspector) Amongthem, quality manager: required college graduation for three yearsSupervisor inspector: required to graduate for three years oflaboratory related major

办理三类医疗器械许可证要求:

1.地址要求:普通类:办公面积不少于100平，仓库面积不少于60平;

2.一次性无菌:办公面积不少于60平，仓库面积不少于80;

3.体外诊断试剂:办公面积不少于60平，仓库面积不少于100平，冷藏室面积不少于20立方

4.人员要求:医学相关专业毕业满三年办理三类医疗器械许可证的注意事项:

1、办公地址需商用性质，面积以房产证上建筑面积为准;

2、体外诊断试剂必须要有冷藏室，且至少20立方，医用冰柜是没用的，必须是冷藏室;因为涉及到后续老师到现场勘查;