(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;办理三类医疗器械经营许可证的办理流程:
(四)应当建立健全产品质量管理制度,包括采购、进货验收、仓储保管、出库
(4)经营场所、仓库的地理位置图、平面图(注明面积)、房屋产权证明或者租赁协议复印件;
(5)企业产品质量管理制度文件及储存设施、设备目录。
(6)对于办理三类医疗器械经营许可证内容包含有需要冷藏的药品时,企业具备的运输装备、仓储设施设备情况表。
、第三类医疗器械经营许可证怎么办理
(1)申请人提交申请资料到相关部门;
(2)相关部门受
e application of the applicant's application; (3) investigatethe actual site and review the product; (4) grant the issuance of aclass III medical device license.2. Legal basis: Article 14 of theRegulations on Supervision and Administration of Medical Devicesfor product filing of Class I medical devices and application forproduct registration of Class II and Class III medical devices, thefollowing materials shall be submitted: (1) product risk analysisdata; (2) technical requirements of the product; (3) productinspection report; procedures for handling the business license ofClass III medical devices: (4) A product quality management systemshall be established and improved, including procurement, purchaseand acceptance, storage and out of storage (4) The business siteand the warehouse of the geographical location map, the floor plan(indicating the area), the house property right certificate or thecopy of the lease agreement; (5) Enterprise product qualitymanagement system documents and catalogue of storage facilities andequipment. (6) Table of transpor