依据《医疗器械监督管理条例》,第三类医疗器械是具备较高危,必须采用非常对策严控管理方法以确保其安全性、合理的医疗机械。例如普遍的注射器、注射针、静脉留置针、心脏支架、麻醉机、CT、磁共振等。
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。
prepared in advance when applying for the Class IIImedical device license (1) Enterprise business license; (2) Companyseal; (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 floor design drawing, warehouse floordesign drawing. Provisions for applying for a class III medicaldevice license (1) The total area of the place and warehouseprovisions: consistent with the scale of the enterprise in theplace of operation. (2) Quality administrator regulations: collegedegree or above or junior professional title, in addition, shouldhave about 3 years of personal experience in medical devicebusiness quality management. (3) Technical professional regulationsof quality administrators: related technical majors of medicalmachinery, such as medicine, pharmacology, biotechnology, nursingmajors, etc. How to do the third-class medical device license Fullyconsidering the relevant laws and regulations and controlprovisions of the pharmaceutical industry, cross-professional staffcannot apply for success or sequelae, I propose to apply for aprofessional third-party service project of medical devices. Due tothe wide range of third-party resources, the basic laws andregulations are all clear, so it is na