海淀温泉医疗器械三类经营许可证二类备案专业办理快捷包下证
类医疗器械经营许可证如何办理
1、三类医疗器械经营许可证办理方式如下:
(1)申请人提交申请资料到相关部门;
(2)相关部门受理申请人的申请;
(3)到实际场地进行勘察以及对产品进行审核;
(4)准予颁发三类医疗器械许可证。
2、法律依据:《医疗器械监督管理条例》第十四条
第一类医疗器械产品备案和申请第二类、第三类医疗器械产品注册,应当提交下列资料:
(一)产品风险分析资料;
(二)产品技术要求;
(三)产品检验报告;
(四)临床评价资料;
(五)产品说明书以及标签样稿;
(六)与产品研制、生产有关的质量管理体系文件;
(七)证明产品安全、有效所需的其他资料。
(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
registration of Class II and III medical devices shall submit the following materials: (1) product risk analysis data; (2) product technical requirements; (3) product inspection report; (4) (4) clinical evaluation data; (5) product specification and label samples; (6) quality management system documents related to product development and production; (7) other materials required to prove the safety and effectiveness of the product. (1) The total area of the place and warehouse provisions: consistent with the scale of the enterprise in the place of operation. (2) Quality administrator regulations: college degree or above or junior professional title, in addition, should have about 3 years of personal experience 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. Class III medical device license how