丰台东大街北京办理医疗器械三类经营许可证没有库房怎么办包下证快捷
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;9、凡申请材料需提交复印件的,申请人(单位)须在复
(四)应当建立健全产品质量管理制度,包括采购、进货验收、仓储保管、出库复核、质量跟踪制度和不良事件的报告制度等;
(五)应当具备与其经营的医疗器械产品相适应的技术培训和售后服务的能力。
(六)具有与经营的医疗器械相适应的质量管理制度。
其次,经营企业要知晓办理三类医疗器械经营许可证需要准备哪些资料。
(1)提交医疗器械经营企业许可证申请表,法定代表人签字或加盖企业公章;
(2)工商行政管理部门出具的
medical devices 1. The business license of medical devices is as follows: (1) the applicant submits the application materials to the relevant departments; (2) the relevant departments accept the application of the applicant; (3) investigate the actual site and review the product; (4) grant the issuance of the medical device license.2. Legal basis: Article 14 of the Regulations on the Supervision and Administration of Medical Devices for the filing of Class I medical devices and the registration of Class II and Class III medical devices, the following data shall be submitted: (1) product risk analysis data; (2) product technical requirements; (3) product inspection report; (4) clinical evaluation data; 9. If the application materials need to be submitted, the applicant (unit) shall establish and improve the product quality management system, including purchase, purchase acceptance, storage, warehouse review, quality tracking system and reporting system of adverse events; (5) It shall have the ability of technical training and after-sales service suitable with the medical devices it operates. (6) It shall have a quality man