门头沟大峪北京医疗器械三类经营许可证二三类专业快捷包拿证

pplicant shall submit theapplication materials to the relevant departments; (2) the relevantdepartments shall accept the application; (3) investigate theactual site and review the products; (4) grant the issuance of thethird III medical device license.2. Legal basis: Article 14 of theRegulations on Supervision and Administration of Medical Devicesfor the filing of Class I medical devices and application for theregistration of Class II and III medical devices shall submit thefollowing materials: (1) product risk analysis data; (2) technicalrequirements (3) product; (3) product inspection report; (4)clinical evaluation data; (5) product instructions and labelsamples; (6) quality management system documents related to productdevelopment and production; (7) other materials required to provethe safety and effectiveness of the product. The product inspectionreport shall meet the requirements of the drug regulatorydepartment under The State Council, and may be the self-inspectionreport of the medical device registration applicant or recordholder, or the inspection report issued by a qualified medicaldevice inspection institution. Those who are exempted from clinicalevaluation in accordance with the provisions of Article 24 of theseRegulations may be exempted from the submission of clinicalevaluation data. The medical device registrationapplicant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；
（七）证明产品安全、有效所需的其他资料。
产品检验报告应当符合国务院药品监督管理部门的要求，可以是医疗器械注册申请人、备案人的自检报告，也可以是委托有资质的医疗器械检验机构出具的检验报告。
符合本条例第二十四条规定的免于进行临床评价情形的，可以免于提交临床评价资料。
医疗器械注册申请人、备案人应当确保提交的资料合法、真实、准确、

pplicant shall submit the application materials to the relevantdepartments; (2) the relevant departments shall accept theapplication; (3) investigate the actual site and review theproducts; (4) grant the issuance of the third III medical devicelicense.2. Legal basis: Article 14 of the Regulations onSupervision and Administration of Medical Devices for the filing ofClass I medical devices and application for the registration ofClass II and III medical devices shall submit the followingmaterials: (1) product risk analysis data; (2) technicalrequirements (3) product; (3) product inspection report; (4)clinical evaluation data; (5) product instructions and labelsamples; (6) quality management system documents related to productdevelopment and production; (7) other materials required to provethe safety and effectiveness of the product. The product inspectionreport shall meet the requirements of the drug regulatorydepartment under The State Council, and may be the self-inspectionreport of the medical device registration applicant or recordholder, or the inspection report issued by a qualified medicaldevice inspection institution. Those who are exempted from clinicalevaluation in accordance with the provisions of Article 24 of theseRegulations may be exempted from the submission of clinicalevaluation data. The medical device registration applicant