海淀中关村医疗器械三类经营许可证二类备案专业办理快捷包下证

疗器械经营许可证如何办理
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；
（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。

审核：预审合格后，医疗器械监督管理部门将进行审核，审核包括企业的组织架构、质量管理体系、产品销售情况等方面。

随着相关制度的逐步完善，市场环境的逐渐向好，医疗器械或将迎来喷涌爆发式的发展。新政策要求：医疗器械经营企业要在经营活动中积极应用唯一标识，做好带码入库、出库，实现产品在流通环节可追溯。

医疗器械经营许可证申请

How to handle the business license of medical devices 1. The business license of third III medical devices is as follows: (1) the applicant submits the application materials to the relevant departments; (2) the relevant departments accept the application of the applicant's application; (3) investigate the actual site and review the product; (4) grant the issuance of the third III medical device license.2. Legal basis: Article 14 of the Regulations on Supervision and Administration of Medical Devices for the filing of Class I medical devices and application for the registration of Class II and III medical devices shall submit the following materials: (1) product risk analysis data; (2) technical requirements (3) product; (3) product inspection report; (4) clinical evaluation data; (5) product instructions and label samples; (6) quality management system documents related to product development and production; (7) other materials required to prove the safety and effectiveness of the product. Set up a medical device business department: set up a special medical device business department in the company to be responsible for the procurement, sales, storage and after-sales service of medical devices. Audit: After the pre-examination, the medical device supervision and management department will conduct the audit, including the organizational structure, quality management system, product sales, etc. With the gradual improvement of relevant systems and the gradual improvement of the market environment, medical devices may usher in the explosive development. The new policy requirements: medical device operating enterprises should actively apply the unique identification in their business activities, do a good job of warehousing and warehousing with codes, and realize the traceability of products in the circulation link. Application for the medical device business license