东城海运仓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
(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)须在复万元以上2万元以下罚款。申请人在3年内不得再次申请《医疗器械经营企业许可证》。
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
departments shall accept the application of the applicant; (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 filing of Class I medical devices and the application for the registration of Class II and Class III medical devices, the following materials shall be submitted: (1) product risk analysis data; (2) product technical requirements; (3) product inspection report; (4) clinical evaluation data; 9. The applicant (unit) shall be fined not less than 10,000 yuan but more than 20,000 yuan. The applicant shall not apply for the Medical Device Business Enterprise License again within 3 years. Procedures for handling the business license of Class III medical devices: 1. Submit doctors to the Food and Drug Administration