(1)申请人提交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;
(五)产品说明书以及标签样稿;
二、三类医疗器械许可证注册需要什么材料10、申请材料应完整、清晰、签字,并逐份加盖公章,所有申请表格电脑打字填写,使用A4纸打印,复印使用A4纸,按照申请材料目录顺序装订成册。:申请人隐瞒有关情况或者提供虚假材料的,省、自治区、直辖市(食品)药品监督管理部门或者接受委托的设区的市级(食品)药品监督管理机构对申请不予受
application materials to the relevant departments; (2) therelevant departments shall accept the application; (3) investigatethe actual site and review the products; (4) grant the issuance ofthe third III medical device license.2. Legal basis: Article 14 ofthe Regulations on the Supervision and Administration of MedicalDevices for the filing of Class I medical devices and theapplication for the registration of Class II and Class III medicaldevices, The following materials shall be submitted: (1) productrisk analysis materials; (2) technical requirements of the product;(3) product inspection report; (4) clinical evaluation materials;(5) product specification and label samples; what materials arerequired for the registration of the license of Class II and IIImedical devices 10, the application materials shall be complete,clear and signed; And affix the official seal on the copy by copy,All application forms are filled out by computer-based typing,Printed using A4 paper, Copying using A4 paper, Bind a book in theorder of application materials.: Where the applicant conceals therelevant information or provides false materials, the (food) drugregulatory department of the province, autonomous region ormunicipality directly under the Central Government or the municipal(food) drug regulatory agency of the entrusted city divided intodistricts shall not accept the appli