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;
(七)证明产品安全、有效所需的其他资料。
(一)具有与经营规模和经营范围相适应的质量管理机构或者质量管理人员两个。质量管理人员应当具有国家认可的相关专业学历或者职称,质量管理人应在职在岗,不得在其他单位兼职;
(二)具有与经营规模和经营范围相适应的相对独立的经营场所;
(三)具有与经营规模和经营范围相适应的储存条件,包括具有符合医疗器械产品特性要求的储存设施、设备;
(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、出库复核、质量跟踪制度和不良事件的报
Investigate the actual site and review the products; (4) grantthe issuance of a class III medical device license.2. Legal basis:Article 14 of the Regulations on Supervision and Administration ofMedical Devices for the filing of Class I medical devices andapplication for the registration of Class II and III medicaldevices shall submit the following materials: (1) product riskanalysis data; (2) technical requirements (3) product; (3) productinspection report; (4) clinical evaluation data; (5) productinstructions and label samples; (6) quality management systemdocuments related to product development and production; (7) othermaterials required to prove the safety and effectiveness of theproduct. (1) It shall have two quality control agencies or qualitymanagement personnel suitable for the scale and scope of itsbusiness operations. The quality management personnel shall havethe relevant professional education background or professionaltitle recognized by the state, and the quality manager shall be onthe job and shall not take part-time jobs in other units; (2)having a relatively independent business site commensurate with thescale and scope of operation; (3) It shall have storage conditionscommensurate with the scale and scope of business, includingstorage facilities and equipment that meet the requirements of thecharacteristics of the medical device products; (4) The productquality management system shall be established and improved,including procurement, purchase and acceptance inspection, storage,warehouse delivery review, quality tracking system and thereporting of adverse events