密云医疗器械三类经营许可证二类备案专业办理快捷包下证

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；
1、企业名称与经营范围，注册资本及股东出资比例，股东等sfz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、sfz明与简历；

5、符合医疗器械经营要求的办公场地及

evice license.2. Legal basis: Article 14 of the Regulations on the Supervision and Administration of Medical Devices and applying for the registration of Class II and Class 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 description and label samples; 1. Enterprise name and business scope, registered capital and shareholder contribution ratio, and shareholders sfzz; 2. Medical device product registration certificate, supplier business license, license and authorization letter; 3. Quality management documents, etc.; 4,2 or more medical professional or related professional certificates, sfz Ming and resume; 5. Office space and facilities that meet the requirements of medical equipment operation