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;
二、三类医疗器械许可证注册需要什么材料
三类医疗器械许可证注册所需材料如下:
1、企业名称与经营范围,注册资本及股东出资比例,股东等身份证明;
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;
bmitted: (1) product risk analysis data; (2) product technicalrequirements; (3) product inspection report; (4) clinicalevaluation data; (5) product description and label samples; (6)quality management system documents related to product developmentand production; what materials required for registration of ClassIII What materials required for registration of Class III medicaldevices are as follows: 1. Enterprise name and business scope: Theproportion of the registered capital and the shareholders' capitalcontribution, Shareholders and other identity certificates; 2,medical device product registration certificate, supplier businesslicense, license and authorization letter; 3, quality managementdocuments, etc.; 4,2 or more medical professional or relatedprofessional certificate, identity certificate and resume; 5,office space and warehouse certificate meeting the requirements ofmedical device operation;