(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
充分考虑医药行业相关法律法规及管控规定许多,跨专业工作人员没办法申请办理取得成功或产生后遗症,
提议找医疗器械专业第三方服务项目组织申请办理。由于第三方资源广,基础的法律法规都一清二楚,提前准备材料自然游刃有余。
duation certificate and other certification materials; (5)Operation floor plan design drawing, warehouse floor plan designdrawing. Provisions on applying for a class III medical devicelicense (1) The total area of the place and warehouse provisions: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 device business qualitymanagement. (3) Technical professional regulations of qualityadministrators: related technical majors of medical machinery, suchas medicine, pharmacology, biotechnology, nursing majors, etc. Howto do the third-class medical device license Fully considering therelevant laws and