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;4、工商行政管理部门出具的《企业名称预先核准通知书》或《工商营业执照》的复印件应与原件相同,复印件确认留存,原件退回;5、房产证明、房屋租赁证明(出租方要提供产权证明)应有效;6、企业负责人、质量管理人的简历、学历证明或职称证明应有效;7、企业应根据自身实际建立医疗器械质量管理档案或表格。8、申请材料真实性的自我保证声明应由法定代表人签字并加盖企
medical device license.2. Legal basis: Article 14 of theRegulations on the Supervision and Administration of MedicalDevices for the filing of Class I medical devices and theapplication for the registration of Class II and Class III medicaldevices, The following materials shall be submitted: (1) productrisk analysis data; (2) technical requirements of the product; (3)product inspection report; (4) clinical evaluation data; (5)product specification and label samples; 4, the copy of the"enterprise name pre-approval notice" or "industrial and commercialbusiness license" issued by the industrial and commercialadministrative department should be the same as the original, Copyof confirmation and retention, The Original copy is returned; 5.The property certificate and house lease certificate (the lessorshall provide the property right certificate) shall be valid; 6.The resume, educational background certificate or professionaltitle certificate of the person in charge of the enterprise and thequality manager shall be valid; 7. The enterprise shall establishthe quality management files or forms of medical devices accordingto its own actual conditions.8. The self-guarantee statem