(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;申请人隐瞒有关情况或者提供虚假材料的,省、自治区、
3.数据正式受理;
4.有关部门的行政审查;
5.现场评价;
6.有关部门的行政决定;
7.制证、发证。
办理三类医疗器械经营许可证的条件如下:
1、具有与经营
ce of a class III medical device license.2. Legal basis: Article 14 of the Regulations on the Supervision and Administration of Medical Devices for Class 1 medical devices and the registration of Class II and III medical devices, the following data shall be submitted: (1) product risk analysis data; (2) product technical requirements; (3) product inspection report; (4) clinical evaluation data; the applicant conceals relevant information, provinces, autonomous regions; 4. administrative examination of relevant departments; 5. On-site evaluation; 6. administrative decisions of relevant departments; 7. certificate making and issuing certificates. The conditions for handling the business license of class III medical devices are as follows: 1. Have and operate