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;
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,
How to handle the medical equipment business license 1. Thebusiness license of Class III medical devices is handled asfollows: (1) The applicant shall submit the application materialsto the relevant departments; (2) Relevant departments shall acceptthe application of the applicant; (3) Investigate the actual siteand audit the products; (4) Grant the issuance of a class IIImedical device license. 2. Legal basis: Article 14 of theRegulations on the Supervision and Administration of MedicalDevices As for the registration of Class II and III medicaldevices, the following materials shall be submitted: (1) Productrisk analysis data; (2) Technical requirements for the products;(3) Product inspection report; (4) Clinical evaluation data; (5)Product specification and label samples; (6) quality managementsystem documents related to product development and production; 1.The operator of the operating enterprise shall bring the aboveinformation to the supervision and administration department toapply for the business license; 2. The staff shall accept thematerials, and review them within 30 working days, and organize theverification if necessary; 3. For those who meet the prescribedconditions,