房山琉璃河医疗器械三类经营许可证二类备案专业办理快捷包下证

（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；

追溯。

二、三类医疗器械许可证注册需要什么材料

三类医疗器械许可证注册所需材料如下：

1、企业名称与经营范围，注册资本及股东出资比例，股东等身份证明；

2、医疗器械产品注册证书、供应商营业执照、许可证及授权书；

3、质量管理文件等；

4、2个或以上医学专业或相关专业人员证书、身份证明与

4) Grant the issuance of a class III medical device license. 2. Legal basis: Article 14 of the Regulations on the Supervision and Administration of Medical Devices As for the registration of Class II and III medical devices, the following materials shall be submitted: (1) Product risk analysis data; (2) Technical requirements for the products; (3) Product inspection report; (4) Clinical evaluation data; (5) Product specification and label samples; (6) quality management system documents related to product development and production; retrospect. 2. What materials are required for the registration of the class III medical device license The materials required for the license registration of Class III medical devices are as follows: 1. Enterprise name and business scope, registered capital and proportion of shareholder contribution, shareholders and other identity certificates; 2. Medical device product registration certificate, supplier business license, license and authorization letter; 3. Quality management documents, etc.; 4,2 or more certificates and identification certificates of medical professionals or related professionals