(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;申请人以欺骗、贿赂等不正当手段取得《医疗器械经营企
办理,在接受资料后的30天内进行审核,如果符合相关规定,就可以颁发三类医疗器械经营许可证。
医疗企业经营许可证一共有
ant 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 the Supervision and Administration of Medical Devices and the application of the registration of Class II and Class III medical devices, the following data shall be submitted: (1) product risk analysis data; (2) product technical requirements; (2) product inspection report; (4) clinical evaluation data; the applicant shall cheat, bribe and review the documents within 30 days after receiving the data, and if the relevant requirements comply, the business license of Class III medical devices can be issued. Medical enterprise operation license in total