on materials to the relevant departments; (2) the relevantdepartments shall accept the application of the applicant; (3)investigate the actual site and review the products; (4) grant theissuance of the third III medical device license.2. Legal basis:Article 14 of the Regulations on the Supervision and Administrationof Medical Devices for the filing of Class I medical devices andthe application for the registration of Class II and Class IIImedical devices, The following materials shall be submitted: (1)product risk analysis data; (2) technical requirements of theproduct; (3) product inspection report; (4) clinical evaluationdata; (5) product specification and label samples; (6) qualitymanagement system documents related to product development andproduction; 1. Distributor of many medical drugs or medical devicessubmitted by the trading enterprise, Without the operating license,A lot of products can't be sold, In vitro diagnostic reagents, forexample, fall into three categories of medical devices, Only withthe relevant certificates, To sell the product.
（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；
（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；1、经营企业提交的《医疗
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医疗器械，只有有相关证书，才能销售这种产品。
