al devices is handled as follows: (1) the applicant submits theapplication materials to the relevant departments; (2) the relevantdepartments accept the application of the applicant; (3)investigate the actual site and review the products; (4) grant theissuance of the Class III medical device license.2. Legal basis:Article 14 of the Regulations on the Supervision and Administrationof Medical Devices and applying for the registration of Class IIand Class III medical devices, the following materials shall besubmitted: (1) product risk analysis data; (2) product technicalrequirements; (3) product inspection report; (4); (4) clinicalevaluation data; (5) product specification and label samples; (6)quality management system documents related to product developmentand production; 1. Medical 7. Certificate preparation andcertification submitted by the operating enterprise. The conditionsfor handling the business license of class III medical devices area
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;1、经营企业提交的《医疗
7.制证、发证。
办理三类医疗器械经营许可证的条件如下:
1、具有与经营