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 (1)the applicant submits the application materials to the relevantdepartments; (2) the relevant departments accept the application ofthe applicant; (3) investigate the actual site and review theproducts; (4) grant the issuance of the Class III medical devicelicense.2. Legal basis: Article 14 of the Regulations on theSupervision and Administration of Medical Devices for the filing ofClass I medical devices and the application for the registration ofClass II and Class III medical devices, the following materialsshall be submitted: (1) product risk analysis data; (2) producttechnical requirements; (3) product inspection report; (4) clinicalevaluation data; 9. The applicant (unit) shall be fined not lessthan 10,000 yuan but more than 20,000 yuan. The applicant shall notapply for the Medical Device Business Enterprise License againwithin 3 years. Procedures for handling the business license ofClass III medical devices: 1. Submit application materials formedical device business license to the Food and DrugAdministration; 2. Examination of data form of the Food and DrugAdministration; 3. Official acceptance of data; 4. Administrativereview of relevant departments; 5. On-siteevaluation;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;9、凡申请材料需提交复印件的,申请人(单位)须在复万元以上2万元以下罚款。申请人在3年内不得申请《医疗器械经营企业许可证》。
办理三类医疗器械经营许可证的办理流程:
1.向食品药品监督管理局提交医疗器械经营许可证申请材料;
2.食品药品监督管理局数据形式审查;
3.数据正式受理;
4.有关部门的行政审查;
5.现场评价;