申请办理三类医疗器械许可证必须提前准备的原材料
(1)企业营业执照;
(2)公司章;
(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,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
als that must be prepared in advance when applying for the ClassIII medical device license (1) Enterprise business license; (2)Company seal; (3) Property right certificate and lease agreement;(4) Identity of legal representative, principal person in charge,quality manager, graduation certificate and other certificationmaterials; (5) Business floor plan design drawing, warehouse floorplan design drawing. Provisions on applying for a class III medicaldevice license (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 orjunior professional title, in addition, should have about 3 yearsof personal experience in medical