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
4)准予颁发三类医疗器械许可证。
二、第三类医疗器械经营许可证办理流程:
1、经营企业经办人携带上述资料前往监督管理部门申请经营许可;
2、工作人员受理资料,并于30个工作日内进行审查,必要时组织核查;
3、对符合规定条件的,准予许可并发给医疗器械经营许可证;对不符合规定条件的,不予许可并书面说明理由。
三、第三类医疗器械经营许可证办理所需材料:
1、企业名称与经营范围,注册资本及股东出资比例,股东等sfz明;
2、医疗器械产品注册证书、供应商营业执照、许可证及授权书;
3、质量管理文件等;
4、2个或以上医学专业或相关专业人员证书、sfz
report; (3) product inspection report; (4) clinical evaluationdata; (5) product instructions and label samples; (6) qualitymanagement system documents related to product development andproduction; 1. Medical 4) approval of Class III medical devicelicense. 2. Process for handling the business license of Class IIIMedical Devices: 1. The operator of the operating enterprise shallbring the above information to the supervision and administrationdepartment to apply for the business license; 2. The staff shallaccept the materials, and review them within 30 working days, andorganize the verification if necessary; 3. Grant license andmedical device operation license for those who meet the prescribedconditions, and give reasons in writing. 3. Materials required forhandling the business license of Class III medical devices: 1, theenterprise name and business scope, the registered capital and theproportion of shareholder contribution, shareholders and other sfzMing; 2. Medical device product registration certificate, supplierbusiness license, license and authorization letter; 3. Qualitymanagement documents, etc.; 4,2 or more certific