(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;
办理,在接受资料后的30天内进行审核,如果符合相关规定,就可以颁发三类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足相关要求。
(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
e product; (4) grant the issuance of a class III medical devicelicense.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 shall submit the followingmaterials: (1) product risk analysis data; (2) product technicalrequirements; (3) product inspection report; (4) clinicalevaluation data; (4) clinical evaluation data; (5) productinstructions and label samples; review within 30 days afterreceiving the data, and if the relevant provisions comply, thebusiness license of Class III medical devices may be issued. Thereare three types of medical enterprise business licenses, amongwhich the first class medical device license can be directlyhandled, the operation of second class products needs to apply forthe record certificate of second class medical devices, and theoperation of third class products needs to apply for the businesslicense of third class medical devices. First of all, the operatingenterprise must clarify the conditions for applying forthe