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
医疗器械经营许可证。
其次,经营企业要知晓办理三类医疗器械经营许可证需要准备哪些资料。
(1)提交医疗器械经营企业许可证申请表,法定代表人签字或加盖企业公章;
(2)工商行政管理部门出具的企业名称预核准证明文件或《营业执照》复印件和校验原件;
(3)企业质量管理负责人的身份证、学历或者职称证明复印件及个人简历;质量管理人员的身份证、学历或者职称证明复印件;
(4)经营场所、仓库的地理位置图、平面图(注明面积)、房屋产权证明或者租赁协议复印件;
data; product description and label samples; (6) system documents related to product development andproduction; 1. Business license of medical and medical devicessubmitted by the operating enterprise. Secondly, the operatingenterprise should know what information it needs to prepare for thethree types of medical e business license. (1) Submit theapplication form for the license of the medical device tradingenterprise, signed by the legal representative or affix theofficial seal of the enterprise; (2) The copy of the pre-approvalcertificate of the enterprise name or the Business License issuedby the administrative department for industry and commerce; (3) acopy of the id card, educational background or professional titlecertificate and personal resume of the management managerof the enterprise; a copy of the ID card, educational background orprofessional title certificate of the management personnel;(4) Copy of the geographical location plan, plan (indicated area),the property right certi