东城交道口医疗器械三类经营许可证二类备案专业办理快捷包下证

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；

医疗器械二类备案流程：1、准备执照副本，公章，实际经营地址房本复印件，租房合同2、需要提供一名质量管理员，医学医护相关专业毕业满3年的3、网上提交医疗器械二类备案审核资料通过后线下交材料 4、经营医疗器械二类批发的企业还需要准备库房 可全程免费指导办理流程，提供质量管理员，也可托管办理，专业速度快速快3天完成备案

法律责任：

申请人隐瞒有关情况或者提供虚假材料的，省、自治区、直辖市（食品）药品监督管理部门或者接受委托的设区的市级（食品）药品监督管理机构对申请不予受理或者不予核发《医疗器械经营企业许可证》，并给予警告。申请人在1年内不得再次申请《医疗器械经营企业许可证》。

1、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。

he applicant shall submit the application materials to therelevant departments; (2) relevant departments shall accept theapplication of the applicant; (3) investigate the actual site andaudit the products; (4) grant the issuance of a class iii medicaldevice license. 2. legal basis: article 14 of the regulations onthe supervision and administration of medical devices as for theregistration of class ii and iii medical devices, the followingmaterials shall be submitted: (1) product risk analysis data; (2)technical re for the products; (3) product inspectionreport; (4) clinical evaluation data; (5) product specificationsand label samples; (6) management system documents relatedto product development and production; medical e classfiling process: 1, prepare the license copy, official seal, theactual business address room this copy, rental contract 2, need toprovide a administrator, medical related professionalgraduate 3 years of 3, online submit medical device class filingaudit data through offline material 4, medical e wholesaleenterprises also need to prepare warehouse can guide process, freeprovide administrator, can also be managed, professionalspeed fast 3 days to complete for the record legal liability: wherethe applicant conceals the relevant information or provides falsematerials, the (food) drug regulatory department of the province,autonomous region or municipality directly under the centralgovernment or the (food) drug regulatory agency of the entrustedcity shall not accept the application or issue the medical devicetrading enterprise license and give it a warning. the applicantshall not apply for the medical device business enterprise licenseagain within one year. many distributors of drugs or medicaldevices can not sell many products without the business license ofthird class medical devices. for example, in vitro diagnosticreagents belong to the third class medical devices, and only withrelevant certificates can such products be sold.