海淀厂洼医疗器械三类经营许可证二类备案专业办理快捷包下证

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。

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

w to handle the business license 1. Class III medical devicebusiness license is as follows: (1) the applicant submits theapplication materials to the relevant departments; (2) the relevantdepartments accept the application of the applicant's application;(3) investigate the actual site and review the products; (4) grantthe issuance of the Class 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. Application materials for submission: Theapplication materials include the application form for medicaldevice business license, the description of the scope of medicaldevice business license, and the company's business