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;
(七)证明产品安全、有效所需的其他资料。
8、其它相关材料。
医疗器械行业是一个重要的领域,工商注册也是必不可少的步骤。对于想要在医疗器械行业创业的人来说,工商注册是必须要进行的一项手续。
申请三类医疗器械经营许可证的步骤和要求如下:
公司注册:需要进行公司注册,注册时应将公司的经营范围与医疗器械经营范围相符,并具备相应的注册资金
How to handle the business license of device 1. Class IIImedical device business license is handled as follows: (1) theapplicant submits the application materials to the relevantdepartments; (2) the relevant departments accept the application ofthe applicant; (3) investigate the actual site and review theproduct; (4) grant the issuance of Class III medical devicelicense.2. Legal basis: Article 14 of the Regulations onSupervision and Administration of Medical Devices for the filing ofClass I medical devices and the application for the registration ofClass II and III medical devices shall submit the followingmaterials: (1) product risk analysis data; (2) technicalrequirements of the product; (3) product inspection report; (4)clinical evaluation data; (5) product instructions and labelsamples; (6) quality management system documents related to productdevelopment and production; (7) other materials required to provethe safety and effectiveness of the product.8. Other relatedmaterials. The medical device industry is an important field, andbusiness registration is also an essential step. For those who wantto start a business in the medical device industry, businessregistration is a must procedure. The steps and requirements forapplying for the business license are as follows: Companyregistration: First of all, the company needs to be registered.When registration, the business scope of the company should beconsistent with the