北京星期三企业管理咨询有限公司业务部
工商注册 , 资质审批 , 代理记账 , 建委资质 , 舞美资质 , 拍卖资质
朝阳南磨房北京医疗器械三类经营许可证,医疗器械二类备案提供人员库房专业快捷包下证

(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;办理三类医疗器械经营许可证的办理流程:
1.向食品药品监督管理局提交医疗器械经营许可证申请材料;
2.食品药品监督管理局数据形式审查;
3.数据正式受理

on materials to the relevant departments; (2) the relevant departments shall accept the application of the applicant's application; (3) investigate the actual site and review the products; (4) grant the issuance of the third III medical device license. 2. Legal basis: Article 14 of the Regulations on the Supervision and Administration of Medical Devices for the registration of Class II and III medical devices, the following materials shall be submitted: (1) product risk analysis data; (2) product technical re; (3) product inspection report; process for handling the business license of Class III medical devices: 1. Submit application materials for business license of medical device to the Food and Drug Administration; 2. Examination of data form of the Food and Drug A


展开全文
相关产品
商铺首页拨打电话发送询价