朝阳广渠门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、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;
(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,
申请人以欺骗、贿赂等不正当手段取得《医疗器械经营企业许可证》的,(食品)药品监督管理部门应当撤销其《医疗器械经营企业许可证》,给予警告,并处1万元以上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;
pplication materials to the relevant departments; (2) the relevant departments accept the application of the applicant; (3) investigate the actual site and review the products; (4) grant the issuance of 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 description and label samples; the filing process of Class II medical devices: 1. Prepare a copy of the license, Where the applicant obtains the Medical Device Trading Enterprise License by improper means of cheating or bribery, the (food) and drug regulatory department shall revoke the Medical Device Trading Enterprise License, give a warning and impose a 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 third III medical device business license: 1. Submit the application materials for medical device business license to the Food and Drug Administration; 2. Data form review of the Food and Drug Administration;