(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;10、申请材料应完整、清晰、签字,并逐份万元以上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
dical device license.2. Legal basis: Article 14 of the Regulations on the Supervision and Administration of Medical Devices and applying for the registration of Class II and Class III medical devices, the following data shall be submitted: (1) product risk analysis data; (2) the product technical requirements; (ii) product inspection report; (4) product inspection report; (4) clinical evaluation data; (5) product specification and label samples; 10, the application materials shall be complete, clear and signed, and impose a fine of between RMB 10,000 yuan but RMB 20,000 yuan. The applicant shall not apply for the Medical Device Business Enterprise License again within 3