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
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。
d warehouse provisions: consistent with the scale of theenterprise in the operating place. (2) Quality administratorregulations: college degree or above or junior professional title,in addition, should have about 3 years of personal experience inmedical device business quality management. (3) Technicalprofessional regulations of quality administrators: relatedtechnical majors of medical machinery, such as medicine,pharmacology, biotechnology, nursing majors, etc. How to do thethird-class medical device license Fully considering the relevantlaws and regulations and control provisions of the pharmaceuticalindustry, cross-professional staff cannot apply for success orsequelae, I propose to apply for a professional third-party serviceproject of medical devices. Due to the wide range of third-partyresources, the basic laws and regulations are all clear, so it isnatural to prepare materials in advance with ease.