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。
(一)具有与经营规模和经营范围相适应的质量管理机构或者质量管理人员两个。
(五)应当具备与其经营的医疗器械产品相适应的技术培训和售后服务的能力。
(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
(一)具有与经营规模和经营范围相适应的质量管理机构或者质量管理人员两个。
(五)应当具备与其经营的医疗器械产品相适应的技术培训和售后服务的能力。
(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
2) The relevant departments accept the application of theapplicant; (3) investigate the actual site and review the products;(4) grant the issuance of the class III medical device license.2.Legal basis: Article 14 of the Regulations on Supervision andAdministration of Medical Devices for the filing of Class I medicaldevices and application for the registration of Class II and IIImedical devices shall submit the following materials: (1) productrisk analysis data; (2) technical requirements (3) product; (3)product inspection report; (4) clinical evaluation data; (5)product instructions and label samples; (6) quality managementsystem documents related to product development and production; (7)other materials required to prove the safety and effectiveness ofthe product. (1) It shall have two quality control agencies orquality management personnel suitable for the scale and scope ofits business operations. (5) It shall have the ability of technicaltraining and after-sales service suitable with the medical devicesit operates. (6) It shall have a quality management system suitablefor the medical devices in operation. Secondly, the operatingenterprise should know what information it needs to prepare for thethree types of medical equipment business license. (1) Submit theapplication form for the medical device business enterpriselicense, and be the legal agent