三类医疗器械经营许可证如何办理
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;
医疗器械二类备案流程:1、准备执照副本,公章,实际经营地址房本复印件,租房合同2、需要提供一名质量管理员,医学医护相关专业毕业满3年的3、网上提交医疗器械二类备案审核资料通过后线下交材料 4、经营医疗器械二类批发的企业还需要准备库房 可全程免费指导办理流程,提供质量管理员,也可托管办理,专业速度快速*快3天完
of Class III medical device 1. The business license of Class IIImedical device is as follows: (1) the applicant submits theapplication materials to the relevant department; (2) the relevantdepartment accepts the application of the applicant; (3)investigate the actual site and review the product; (4) grant theClass III medical device license.2. Legal basis: Article 14 of theRegulations on the Supervision and Administration of MedicalDevices for the filing of Class I medical devices and theapplication for the registration of Class II and Class III medicaldevices, The following materials shall be submitted: (1) productrisk analysis data; (2) technical requirements of the product; (3)product inspection report; (4) clinical evaluation data; (5)product specification and label samples; filing process of medicaldevices: 1. Prepare a copy of the license, official seal, A copy ofthe actual business address room, 2. A quality administrator shallbe provided, Medical care related major graduation for 3 years 3,online submission of medical device class II record audit materialsthrough the offline delivery of materials 4, operating medicaldevice class II wholesale enterprises also need to prepare thewarehouse can be the whole free guidance process, Provides thequality administrators, Can also be managed for handling,Professional spee