东城东直门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;
(四)临床评价资料;
(五)产品说明书以及标签样稿;
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
relevant departments; (2) the relevant 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 Supervision and Administration of Medical Devices for filing of Class I medical devices and application for 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) product evaluation report; (4) clinical evaluation data; (5) product description and label samples; fine of not less than 10,000 yuan but not 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. To the food and drug supervi