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、经营企业提交的《医疗
医疗器械经营许可证。
医疗企业经营许可证一共有三类,其中办理一类医疗器械许可证可以直接办理,经营二类产品是需要办理二类医疗器械经营备案凭证,经营三类产品则需要办理三类医疗器械经营许可证。经营企业必须明确申请三类医疗器械经营许可证的条件并满
the products; (4) grant the issuance of a class III medicaldevice license.2. Legal basis: Article 14 of the Regulations onSupervision and Administration of Medical Devices for the filing ofClass I medical devices and application for the registration ofClass II and III medical devices, the following materials shall besubmitted: (1) product risk analysis data; (2) product technicalrequirements; (3) product technical requirements; (3) productinspection report; (5); (5) clinical evaluation data; productspecification and label samples; (6) quality management systemdocuments related to product development and production; 1.Business license of medical and medical devices submitted by theoperating enterprise. There are three types of medical enterprisebusiness licenses, among which the first class medical devicelicense