北京市东城北京医疗器械三类经营许可证提供人员库房专业快捷包下证
(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、具有与经营范围相匹配的经营场所和仓库,并对其具体面积有具体要求;
2、具有国家认可的、与经营产品相关专门的在岗人员;
nse.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, etc.; 4. administrative examination of relevant departments; 5. On-site evaluation; 6. administrative decisions of relevant departments; 7. making and issuing certificates. The conditions for applying for the business license of Class III medical devices are as follows: 1. Having business premises and warehouses matching the business scope, and having specific requirements for their specific area; 2. Having state-recognized special personnel related to the busines