东城北新桥医疗器械三类经营许可证二类备案专业办理快捷包下证

医疗器械经营许可证办理方式如下：

（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；

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》。

申请人以欺骗、贿赂等不正当手段取得《医疗器械经营企业许可证》的，（食品）药品监督管理部门应当撤销其《医疗器

the medical device business license is handled as follows: (1)the 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 specification andlabel samples; (6) management system documents related toproduct development and production; medical e class filingprocess: 1, prepare the license copy, official seal, the actualbusiness address room this copy, rental contract 2, need to providea administrator, medical related professional graduate 3years of 3, online medical device class filing audit data throughoffline material 4, medical e class wholesale warehousealso need to guide the free process, provide administrator,also can hosting, professional speed fast 3 days to complete forthe record legal liability: where the applicant conceals therelevant information or provides false materials, the (food) drugregulatory department of the province, autonomous region ormunicipality directly under the central government or the (food)drug regulatory agency of the entrusted city divided into districtsshall 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. where the applicant obtains the medicaldevice trading enterprise license by improper means of cheating orbribery, the (food) and drug supervisory and administrativedepartment shall revoke the medical device