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;
(五)产品说明书以及标签样稿;
(六)与产品研制、生产有关的质量管理体系文件;
3、具有与经营产品相关的拥有中专以上学历的技术人员;
4、拥有与经营的医疗器械相适应的质量管理制度
很多药品或者医疗器械的经销商,如果没有三类医疗器械经营许可证,很多产品就不能卖,比如说体外诊断试剂就属于三类
the application of the applicant; (3) surveys the actual siteand examines the product; (4) approves the issuance of thethird-class medical device license.2. Legal basis: Article 14 ofthe Regulations on Supervision and Administration of MedicalDevices for the filing of Class I medical devices and applicationfor the registration of Class II and Class III medical devices, thefollowing data shall be submitted: (1) product risk analysis data;(2) product; (3) product technical requirements; (3) productinspection report; (4) clinical evaluation data; (5) productdescription and label samples; (6) quality management systemdocuments related to product development and production; 3. Havingtechnical personnel with technical secondary school degree orabove; 4. Having quality management system suitable to theoperation of medical devices Many distributors of drugs or medicaldevices can not sell many products without the business license ofClass III medical devices. For example, in vitro diagnosticreagents belong to Class III