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;
(六)与产品研制、生产有关的质量管理体系文件;6.有关部门的行政决定;
库房收拾一下,然后领取《医疗器械经营企业许可申请表》并填写,并把企业相关资质全部带上,还需要带上质量人员的相关资料。
(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。质量管理人员应当具有国家认可的相关专业学历或者职称,质量管理人应在职在岗,不得在其他单位兼职;
lication of the applicant; (3) investigate the actual site and review the product; (4) grant the Class III medical device license.2. Legal basis: Article 14 of the Regulations on the Supervision and Administration of Medical Devices for the filing of Class I medical devices and the application for the registration of Class II and Class III medical devices, The following materials shall be submitted: (1) product risk analysis data; (2) technical requirements of the product; (3) product inspection report; (4) clinical evaluation data; (5) product specification and label samples; (6) quality management system documents related to product development and production; 6. Administrative decisions of relevant departments; clear up the warehouse, Then get the "Medical Device Business Enterprise License Application Form" and fill in, And bring all the relevant qualifications of the enterprise, Also need to bring the relevant information of the quality personnel. (1) It shall have two quality control agencies or quality management personnel suitable for the scale and scope of its business operations. The quality management personnel shall have relevant professional qualifications or professional titles recognized by the state, and the quality manager shall be on duty and shall not take part-time jobs in other units;