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;
3、人员必须是本科医疗行业的，后续办理三类医疗器械许可证，那边老师要约谈的，这人员很重要，不能挂靠，年检也是涉及人员的，办理三类医疗
1. What is a medical device? Beijing wants tounderstand the enterprises to see here Medical device: refers toinstruments, equipment, appliances, materials or other articlesused individually or in combination, including required software;their function on the surface of the body is not obtained bypharmacological, immunology or metabolic means, but may participateand play a certain auxiliary role. 2. How many categories aremedical devices divided into? There are three categories: Theoperation of the first type of medical devicesdoes
