朝阳望京北京医疗器械三类经营许可证，医疗器械二类备案提供进销存软件人员专业快捷包下证

ments of the product; (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; 1. The Application Form for Medical Device Business Enterprise License submitted by the operating enterprise shall be signed by the legal representative or affixed with the official seal of the enterprise; 2. The items filled in the Application Form for License of Medical Device Business Enterprises should be complete and accurate; 3. The identity certificate, academic title certificate and appointment documents of the legal representative shall be valid; 4, the copy of the "enterprise name pre-approval notice" or "industrial and commercial business license" issued by the industrial and commercial administrative department should be the same as the original, Copy of confirmation and retention, The Original copy is returned; 5. The property certificate and house lease certificate (the lessor shall provide the property right certificate) shall be valid; 6. The resume, educational background certificate or professional title certificate of the person in charge of the enterprise and the quality manager shall be valid; 7. The enterprise shall establish the quality management files or forms of medical devices according to 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。