朝阳京广桥北京医疗器械三类经营许可证二三类专业快捷包拿证

）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。

1、经营企业经办人携带上述资料前往监督管理部门申请经营许可；

2、工作人员受理资料，并于30个工作日内进行审查，必要时组织核查；

3、对符合规定条件的，准予许可并发给医疗器械经营许可证；对不符合规定条件的，不予许可并书面

nvestigate the actual site and audit the products; (4) Grant theissuance of a class III medical device license. 2. Legal basis:Article 14 of the Regulations on the Supervision and Administrationof Medical Devices As for the registration of Class II and III, thefollowing materials shall be submitted: (1) Product risk analysisdata; (2) Technical requirements for the products; (3) Productinspection report; (4) Clinical evaluation data; (5) Productspecification and label samples; (6) quality management systemdocuments related to product development and production; (7) othermaterials required to prove the safety and effectiveness of theproduct. 1. The operator of the operating enterprise shall bringthe above information to the supervision and administrationdepartment to apply for the business license; 2. The staff shallaccept the materials and review them within 30 working days, andorganize verification if necessary; 3. To meet the prescribedconditions, grant the license and issue the medical device businesslicense; to do not meet the prescribed conditions, the licenseshall not be granted and written in writin