东城安定门医疗器械三类经营许可证二类备案专业办理快捷包下证

1、三类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

The business license of Class III medical devices is handled as follows: (1) The applicant shall submit the application materials to the relevant departments; (2) Relevant departments shall accept the application of the applicant; (3) Investigate the actual site and audit the products; (4) Grant the issuance of a class III medical device license. 2. Legal basis: Article 14 of the Regulations on the Supervision and Administration of Medical Devices The following materials shall be submitted for registration of Class II and Class III medical devices and shall be submitted: (1) Product risk analysis data; (2) Technical requirements for the products; (3) Product inspection report; (4) Clinical evaluation data; (5) Product specifications and label samples; (6) quality management system documents related to product development and production; Medical equipment class filing process: 1, prepare the license copy, official seal, the actual business address room this copy, rental contract 2, need to provide a quality administrator, medical related professional graduate full 3 years of 3, online submit medical device class filing audit data through offline material 4, medical equipment class wholesale enterprises also need to prepare warehouse can guide process, free provide quality administrator, also can hosting, professional speed fast fastest 3 days to complete for the record legal liability: Where the applicant conceals the relevant information or provides false materials, the (food) drug regulatory department of the province, autonomous region or municipality directly under the Central Government or the entrusted distric