、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;
(七)证明产品安全、有效所需的其他资料。
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
The methods for handling the business license of Class IIImedical devices are as follows: (1) the applicant submits theapplication materials to the relevant departments; (2) the relevantdepartments accept the application of the applicant; (3)investigate the actual site and review the products; (4) grant theissuance of the Class III medical device license.2. Legal basis:Article 14 of the Regulations on Supervision and Administration ofMedical Devices For the filing of Class I medical devices and theapplication for the registration of Class II and III medicaldevices, the following materials shall be submitted: (1) productrisk analysis data; (2) technical requirements of the product; (3)product inspection report; (4) clinical evaluation data; (5)product instructions and label samples; (6) quality managementsystem documents related to product development and production; (7)other materials required to prove the safety and effectiveness ofthe product. Procedures for handling the business license of ClassIII medical devices: 1. Submit the application materials for themedical device business license to the Food and DrugAdministration; 2. Review of the data form of the Food and DrugAdministration; 3. Official acceptance of the data; 4. Related