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,另外理应具备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。
ience in medical device business quality management. (3) Technical professional regulations of quality administrators: related technical majors of medical machinery, such as medicine, pharmacology, biotechnology, nursing majors, etc. How to do the third-class medical device license Fully considering the relevant laws and regulations and control provisions of the pharmaceutical industry, cross-professional staff cannot apply for success or sequelae, I propose to apply for a professional third-party service project of medical devices. Due to the wide range of third-party resources, the basic laws and regulations are