大兴黄村北京医疗器械三类经营许可证二三类专业快捷包拿证
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、企业名称与经营范围,注册资本及股东出资比例,股东等sfz明;
2、医疗器械产品注册证书、供应商营业执照、许可证及授权书;
3、质量管理文件等;
4、2个或以上医学专
he applicant shall submit the application materials to the relevant departments; (2) the relevant departments shall accept the application; (3) investigate the actual site and review the products; (4) grant the issuance of the third III medical device license.2. Legal basis: Article 14 of the Regulations on Supervision and Administration of Medical Devices For the filing of Class I medical devices and application for the registration of Class II and Class III medical devices, the following data shall be submitted: (1) product risk analysis data; (2) product technical requirements; (3) product inspection report; (4) (4) clinical evaluation data; (5) product description and label samples; (6) quality management system documents related to product development and production; 1. enterprise name and business scope, registered capital and proportion of shareholder contribution, and shareholders; 2. Medical device product registration certificate, supplier business license, license and authorization letter; 3. Quality management documents, etc.; 4, and 2 or more medical specialties