(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;
追溯。
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;
-class medical device license.2. Legal basis: Article 14 of theRegulations on Supervision and Administration of Medical DevicesFor the filing of Class I medical devices and the application forthe registration of Class II and III medical devices, the followingmaterials shall be submitted: (1) product risk analysis data; (2)product technical requirements; (3) product inspection report; (4)clinical evaluation data; (5) product instructions and labelsamples; (6) quality management system documents related to productdevelopment and production; traceability.2. The materials requiredfor the registration of medical device license are as follows: 1.Enterprise name and business scope, registered capital andproportion of shareholder contribution, identity certificates ofshareholders; 2. Medical device product registration certificate,supplier business license, license and letter of authorization; 3.Quality management documents, etc.; 4,2 or more medicalprofessionals or related professionals;