丰台西客站医疗器械三类经营许可证二类备案专业办理快捷包下证

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》。

申请三类医疗器械经营许可证的步骤和要求如下：

公司注册：首先，需要进行公司注册，注册时应将公司的经营范围与医疗器械经营范围相符，并具备相应的注册资金、地址、人员等条件。

设立医疗器械经营部门：在公司内设立

handled as follows: (1) the applicant shall submit theapplication materials to the relevant departments; (2) relevantdepartments shall accept the application of the applicant; (3)investigate the actual site and audit the products; (4) grant theissuance of a class iii medical device license. 2. legal basis:article 14 of the regulations on the supervision and administrationof medical devices as for the registration of class ii and iiimedical devices, the following materials shall be submitted: (1)product risk analysis data; (2) technical re for theproducts; (3) product inspection report; (4) clinical evaluationdata; (5) product specification and label samples; (6) system documents related to product development andproduction; medical e class filing process: 1, prepare thelicense copy, official seal, the actual business address room thiscopy, rental contract 2, need to provide a administrator,medical related professional graduate 3 years of 3, online medicaldevice class filing audit data through offline material 4, medicale class wholesale enterprises also need to prepare thewarehouse guidance process, free guidance 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. the steps and re for applying forthe business license are as follows: company registration: first ofall, the company needs to be registered. when registration, thebusiness scope of the company should be consistent with thebusiness scope of medical devices, and the corresponding registeredcapital, address and personnel should be met. establishment of amedical device business department: established in the comp