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。
(六)具有与经营的医疗器械相适应的质量管理制度。
经营企业要知晓办理三类医疗器械经营许可证需要准备哪些资料。
(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
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 the Supervision and Administration of MedicalDevices and apply for the registration of Class II and III medicaldevices shall submit the following materials: (1) product riskanalysis data; (2) product technical requirements; (3) productinspection report; (4) (4) clinical evaluation data; (5) productspecification and label samples; (6) quality management systemdocuments related to product development and production; (7) othermaterials required to prove the safety and effectiveness of theproduct. (6) It shall have a quality management system suitable forthe medical devices in operation. Secondly, the operatingenterprise should know what information it needs to prepare for thebusiness license of three types of medical equipment. (1) Submitthe application form for the license of the medical deviceoperating enterprise, signed by the legal representative or affixthe official seal of the enterprise; (2) The pre-approvalcertificate of the enterprise name issued by the administrativedepartment for industry and commerce or the ying