丰台世界公园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；
（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、完

1. the business license of class iii medical devices is handledas follows: (1) the applicant submits the application materials tothe relevant departments; (2) the relevant departments accept theapplication of the applicant; (3) investigate the actual site andreview the products; (4) grant the issuance of the class iiimedical 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) technicalre (3) product; (3) product inspection report; (4)clinical evaluation data; (5) product instructions and labelsamples; (6) 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 re 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 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 registration applicant and applicant ofmedical devices shall ensure that the submitted materials arelegal,