朝阳水碓子医疗器械三类经营许可证二类备案专业办理快捷包下证

三类医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。

3、具有与经营产品相关的拥有中专以上学历的技术人员；
5、三类医疗器械经营许可证，需要直接去市级人民政府食品药品监督管理部门办理，在接受资料后

How to handle the business license of Class III medical device 1. The business license of Class III medical devices is as follows: (1) the applicant submits the application materials to the relevant departments; (2) the relevant department accepts the application of the applicant; (3) investigate the actual site and review the product; (4) grant the issuance of the Class 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 the application for the registration of Class II and III medical devices, the following materials shall be submitted: (1) product risk analysis data; (2) product technical requirements; (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. 3. Technical personnel with technical secondary school education or above related to the business products; 5. Business license of Class III medical devices needs to go directly to the food and drug supervision and administration department of the municipal people's government after receiving the materials