申请资料到相关部门;
(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;
(四)临床评价资料;
办理三类医疗器械经营许可证的条件如下:
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;
ents; (2) the relevant departments shall accept the applicationof the applicant; (3) investigate the actual site and review theproducts; (4) grant the issuance of the third III medical devicelicense.2. Legal basis: Article 14 of the Regulations onSupervision and Administration of Medical Devices for the filing ofClass I medical device products and the application for theregistration of Class II and III medical devices, the followingmaterials shall be submitted: (1) risk analysis data of productrisk analysis; (2) technical requirements of the product; (3)product inspection report; (4) clinical evaluation data; theconditions for handling the business license of Class III medicaldevices are as follows: There are three types of medical enterprisebusiness licenses, among which the first class medical devicelicense can be directly handled, the operation of second classproducts needs to apply for the record certificate of second classmedical devices, and the operation of third class products needs toapply for the business license of third class medical devices.First of al