朝阳水碓子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

 the product; (4) grant the issuance of a class III medical device license.2. Legal basis: Article 14 of the Regulations on Supervision and Administration of Medical Devices and the registration of Class II and III medical devices shall submit the following data: (1) product risk analysis data; (2) product technical re; (3) product inspection report; (4) product clinical evaluation data; (5) product description and label samples; (6) management system documents related to product development and production; 1. Medical treatment submitted by the operating enterprise Procedures for handling the business license of Class III medical devices: 1. Submit application materials for medical device business license to the Food and Drug Administration; 2. examination of data forms of the Food and Drug Administration; 3. Official acceptance of data; 4. Administrative review of relevant departments; 5. On-site evaluation; 6. administrative decisions of 

（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

办理三类医疗器械经营许可证的办理流程：
1.向食品药品监督管理局提交医疗器械经营许可证申请材料；
2.食品药品监督管理局数据形式审查；
3.数据正式受理；
4.有关部门的行政审查；
5.现场评价；
6.有关部门的行政决定；