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;
4、2个或以上医学专业或相关专业人员证书、身份证明与简历;
5、符合医疗器械经营要求的办公场地及仓库证明;
6、公司章程、股东会决议等;
7、财务人员身份证
w to handle the equipment business license 1. The businesslicense of Class III medical devices is handled as follows: (1) Theapplicant shall submit the application materials to the relevantdepartments; (2) Relevant departments shall accept the applicationof the applicant; (3) Investigate the actual site and audit theproducts; (4) Grant the issuance of a class III medical devicelicense. 2. Legal basis: Article 14 of the Regulations on theSupervision and Administration of Medical Devices As for theregistration of Class II and III medical devices, the followingmaterials shall be submitted: (1) Product risk analysis data; (2)Technical requirements for the products; (3) Product inspectionreport; (4) Clinical evaluation data; (5) Product specification andlabel samples; (6) quality management system documents related toproduct development and production; 4,2 or more certificates,identification certificate and resume of medical professionals orrelated professionals; 5. Office space and warehouse certificatethat meet the business requirements of medical equipment; 6.Articles of association, resolutions of shareholders' meeting,etc.; 7. ID card of financial p