(3)房屋产权证明、租赁协议;
(4)法定代表人、主要负责人、品质管理员的身份、毕业证等证明材料;
(5)经营地平面设计图,仓库平面设计图。
申请办理三类医疗器械许可证的规定
(1)场所和仓库总面积规定:与经营地企业规模相一致。
(2)品质管理员规定:专科本科以上学历或是初级左右专业职称,另外理应具备3年左右医疗器械经营品质管理方面亲身经历。
(3)品质管理员技术专业规定:医疗机械有关技术专业,例如:医药学、药理学、生物技术、护理专业等。
三类医疗器械许可证怎么样办
1) The total area of the place and warehouse: consistent with the scale of the enterprise in the operating place. (2) Quality administrator regulations: college degree or above or junior professional title, in addition, should have about 3 years of personal experience in medical device business quality management. (3) Technical professional regulations of quality administrators: related technical majors of medical machinery, such as medicine, pharmacology, biotechnology, nursing majors, etc. How to do the third-class medical device license