（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；

医疗器械二类备案流程： 1、准备执照副本，公章，实际经营地址房本复印件，租房合同 2、需要提供一名质量管理员，医学医护相关专业毕业满3年的 3、网上提交医疗器械二类备案审核资料通过后线下交材料 4、经营医疗器械二类批发的企业还需要准备库房 可全程免费指导办理流程，提供质量管理员，也可托管办理，专业速度快速快3天完成备案

法律责任：

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年内不得再次申请《医疗器械经营企业许可证》。

申请人以欺骗、贿赂等不正当手段取得《医疗器械经营企业许可证》的，（食品）药品监督管理部门应当撤销其《医疗器械经营企业许可证》，给予警告，并处1万元以上2万元以下罚款。申请人在3年内不得再次申请《医疗器械经营企业许可证》。

办理三类医疗器械经营许可证的办理流程：

1.向食品药品监督管理局提交医疗器械经营许可证申请材料；

2.食品药品监督管理局数据形式审查；

3.数据正式受理；

4.有关部门的行

) The applicant shall submit the application materials to the relevant departments; (2) Relevant departments shall accept the application of the applicant; (3) Investigate the actual site and audit the products; (4) Grant the issuance of a class III medical device license. 2. Legal basis: Article 14 of the Regulations on the Supervision and Administration of Medical Devices As for the registration of Class II and III medical devices, the following materials shall be submitted: (1) Product risk analysis data; (2) Technical requirements for the products; (3) Product inspection report; (4) Clinical evaluation data; (5) Product specification and label samples; (6) quality management system documents related to product development and production; Medical equipment class filing process: 1, prepare the license copy, official seal, the actual business address room this copy, rental contract 2, need to provide a quality administrator, medical related professional graduate 3 years of 3, online submit medical device class filing audit data through offline material 4, medical equipment wholesale warehouse also need to prepare guidance process, free guidance quality administrator, also can hosting, professional speed fast 3 days to complete for the record legal liability: Where the applicant conceals the relevant information or provides false materials, the (food) drug regulatory department of the province, autonomous region or municipality directly under the Central Government or the (food) drug regulatory agency of the entrusted city shall not accept the application or issue the Medical Device Trading Enterprise License and give it a warning. The applicant shall not apply for the Medical Device Business Enterprise License again within one year. Where the applicant obtains the "Medical Device Trading Enterprise License" by improper means of cheating or bribery, the (food) and drug regulatory department shall revoke the "Medical Device Trading Enterprise License", give a warning and impose a fine of not less than 10,000 yuan but not more than 20,000 yuan. The applicant shall not apply for the Medical Device Business Enterprise License again within 3 years. Procedures for handling the business license of Class III medical devices: 1. Submit the application materials for medical device business license to the Food and Drug Administration; 2. Data form review of the Food and Drug Administration; 3. Formal acceptance of data; 4. Action of the relevant departments