大兴兴华大街北京医疗器械三类经营许可证二三类专业快捷包拿证
(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;
3、具有与经营产品相关的拥有中专以上学历的技术人员;
4、拥有与经营的医疗器械相适应的质量管理制度
(1)提交医疗器械经营企业许可证申请表,法定代表人签字或加盖企业公章;
(2)工商行政管理部门出具的企业名称预核准证明文件或《营业执照》复印件和校验原件;
(3)企业质量管理负责人的身份证、学历或者职称证明复印件及个人简历;质量管理人员的身份证、学历或者职称证明复印件;
Investigate the actual site and review the product; (4) grant the issuance of a class III medical device license.2. Legal basis: Article 14 of the Regulations on Supervision and Administration of Medical Devices for the filing of Class I medical devices and application for the registration of Class II and Class III medical devices, the following data shall be submitted: (1) product risk analysis data; (2) product technical requirements; (3) product inspection report; (4) clinical evaluation data; (5) product description and label samples; (6) quality management system documents related to product development and production; 3. Having technical personnel with technical secondary school degree or above; 4. Having quality management system corresponding to the operation of medical devices (1) Submit the application form for the license of the medical device trading enterprise, signed by the legal representative or affix the official seal of the enterprise; (2) The copy of the pre-approval certificate of the enterprise name or the Business License issued by the administrative department for industry and commerce; (3) a copy of the id card, educational background or professional title certificate and personal resume of the quality management manager of the enterprise; a copy of the ID card, educational background or professional title certificate of the quality management personnel;