朝阳望京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
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;医疗器械二类备案流程: 1、准备执照副本,
3、具有与经营产品相关的拥有中专以上学历的技术人员;
4、拥有与经营的医疗器械相适应的质量管理制度
很多药品或者医疗器械的经销商,如果没有
ess license are 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 reviews the products; (4) grant the issuance of the Class III medical device license.2. Legal basis: Article 14 of the Regulations on Supervision and Administration of Medical Devices for the filing of Class I medical devices and the application for the 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) clinical evaluation data; (5) product instructions and label samples; filing process of medical devices: 1, prepare license copies, 3, technical personnel with technical secondary school education related to the products; 4, have a quality management system suitable to the medical devices Many distributors of drug or medical devices, if not