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,
3.数据正式受理;
4.有关部门的行政审查;
5.现场评价;
6.有关部门的行政决定;
7.制证、发证。
办理三类医疗器械经营许可证的条件如下:
1、具有与经营范围相匹配的
siness license of Class III medical devices is handled as follows: (1) the applicant submits the application materials to the relevant departments; (2) the relevant departments accept the application of the applicant; (3) investigate the actual site and review the product; (4) grant the issuance of the Class III medical device license.2. Legal basis: Article 14 of the Regulations on Supervision and Administration of Medical Devices for filing of Class I medical devices and application for registration of Class II and Class III medical devices, the following materials shall be submitted: (1) product risk analysis data; (2) product technical requirements; (2) product technical requirements; (3) product inspection report; (4) clinical evaluation data; (5) product instructions; and label samples; filing process of medical devices: 1. Preparation of license copies; 3. Official acceptance of data; 4. Administrative review of relevant departments; 5. On-site evaluation; 6. Administrative decisions of relevant departments; 7. Certificate preparation and issuance. The conditions for handling the business license of Class III medical devices are as follows: 1. It matches the business scope