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。
plying for the Class III medical device license (1) Enterprisebusiness license; (2) Company seal; (3) Property right certificateand lease agreement; (4) Identity of legal representative,principal person in charge, quality manager, graduation certificateand other certification materials; (5) Operation floor plan designdrawing, warehouse floor plan design drawing. Provisions onapplying for a class III medical device license (1) The total areaof the place and warehouse provisions: consistent with the scale ofthe enterprise 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 p
