ments of the product; (3) product inspection report; (4)clinical evaluation data; (5) product specification and labelsamples; (6) quality management system documents related to productdevelopment and production; 1. The Application Form for MedicalDevice Business Enterprise License submitted by the operatingenterprise shall be signed by the legal representative or affixedwith the official seal of the enterprise; 2. The items filled inthe Application Form for License of Medical Device BusinessEnterprises should be complete and accurate; 3. The identitycertificate, academic title certificate and appointment documentsof the legal representative shall be valid; 4, the copy of the"enterprise name pre-approval notice" or "industrial and commercialbusiness license" issued by the industrial and commercialadministrative department should be the same as the original, Copyof confirmation and retention, The Original copy is returned; 5.The property certificate and house lease certificate (the lessorshall provide the property right certificate) shall be valid; 6.The resume, educational background certificate or professionaltitle certificate of the person in charge of the enterprise and thequality manager shall be valid; 7. The enterprise shall establishthe quality management files or forms of medical devices accordingto its own actual sit
（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《医疗器械经营企业许可证申请表》应有法定代表人签字或加盖企业公章；2、《医疗器械经营企业许可证申请表》所填写项目应填写齐全、准确；3、法定代表人的身份证明、学历职称证明、任命文件应有效；4、工商行政管理部门出具的《企业名称预先核准通知书》或《工商营业执照》的复印件应与原件相同，复印件确认留存，原件退回；5、房产证明、房屋租赁证明（出租方要提供产权证明）应有效；6、企业负责人、质量管理人的简历、学历证明或职称证明应有效；7、企业应根据自身实际建立医疗器械质量管理档案或表格。
