海淀紫竹桥医疗器械三类经营许可证二类备案专业办理快捷包下证

The business license is handled as follows: (1) the applicantsubmits the application materials to the relevant departments; (2)the relevant departments accept the application of the applicant;(3) investigate the actual site and reviews the products; (4) grantthe issuance of the third III medical device license.2. Legalbasis: Article 14 of the Regulations on Supervision andAdministration of Medical Devices for the filing of Class I medicaldevices and application for the registration of Class II and IIImedical devices shall submit the following materials: (1) productrisk analysis data; (2) technical requirements (3) product; (3)product inspection report; (4) clinical evaluation data; (5)product instructions and label samples; (6) quality managementsystem documents related to product development and production; (7)other materials required to prove the safety and effectiveness ofthe product. Set up a medical device business department: set up aspecial medical device business department in the company to beresponsible for the procurement, sales, storage and after-salesservice of medical devices. Professionals: hire professionals withrelevant medical device business experience, such as responsibleperson, registered personnel, management personnel, technicalpersonnel, etc. Submit the application materials: submit theapplication materials including medical device business licenseapplication form, the medical device business license issued scope,the company business license, organization code certificate, taxregistration certificate, legal representative id card, medicaldevice business and technical personnel of appointment, theenterprise drug management quality management system and itsimplementation, medical equipment procurement channels

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；
（七）证明产品安全、有效所需的其他资料。
设立医疗器械经营部门：在公司内设立专门的医疗器械经营部门，负责医疗器械的采购、销售、仓储和售后服务等工作。

聘请专业人员：聘请具有相关医疗器械经营经验的专业人员，如负责人、注册人员、经营管理人员、技术人员等。

提交申请材料：提交申请材料包括医疗器械经营许可证申请表、医疗器械经营许可证颁发范围的说明、公司营业执照、组织机构代码证、税务登记证、法人代表身份证、医疗器械经营负责人和技术人员的聘书、企业的药品经营质量管理规范制度及其实施情况、医疗器械的采购渠道