ation materials to the relevant departments; (2) the relevantdepartments accept the application of the applicant; (3)investigate the actual site and review the products; (4) grant theissuance of class III medical device license.2. Legal basis:Article 14 of the Regulations on the Supervision and Administrationof Medical Devices for the filing of Class I medical devices andthe application for the registration of Class II and Class IIImedical devices, The following materials shall be submitted: (1)product risk analysis data; (2) technical requirements of theproduct; (3) product inspection report; (4) clinical evaluationdata; (5) product specification and label samples; (6) qualitymanagement system documents related to product development andproduction; 1. concealing the relevant information or providingfalse materials submitted by the operating enterprise, The (food)and drug regulatory department of the province, autonomous region,municipality directly under the Central Government or the entrusted(food) and drug regulatory agency of the city divided intodistricts shall not accept the application or issue the MedicalDevice Trading Enterprise License, And give a warning. Theapplicant shall not apply for the Medical Device Business E
1、三类医疗器械经营许可证办理方式如下：
（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；
（六）与产品研制、生产有关的质量管理体系文件；1、经营企业提交的《医疗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理或者不予核发《医疗器械经营企业许可证》，并给予警告。申请人在1年内不得申请《医疗器械经营企业许可证》
