(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;
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三类,其中办理一类医疗器械许可证可以直接办理,经营二类产品是需要
te the actual site and review the product; (4) grant theissuance of a class III medical device license.2. Legal basis:Article 14 of the Regulations on Supervision and Administration ofMedical Devices and application for registration of medicaldevices, the following materials shall be submitted: (1) productrisk analysis data; (2) product technical requirements; (3) productinspection report and (4) clinical evaluation data; The audit shallbe conducted within 30 days after receiving the materials. If therelevant regulations are met, the business license of Class IIImedical devices can be issued. There are three kinds of medicalenterprise business licenses, among which the first class medicaldevice license can be applied directly for, and it is necessary tooperate the second class products