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 onthe Supervision and Administration of Medical Devices and applyingfor the registration of Class II and Class III medical devices, thefollowing materials shall be submitted: (1) product risk analysisdata; (2) product technical requirements; (3) product inspectionreport; (4) clinical evaluation data; (5) product description andlabel samples; 1. Enterprise name and business scope, registeredcapital and shareholder contribution ratio, and shareholders sfzz;2. Medical device product registration certificate, supplierbusiness license, license and authorization letter; 3. Qualitymanagement documents, etc.; 4,2 or more medical professional orrelated professional certificates, sfz Ming and resume; 5. Officespace and facilities that meet the requirements of medicalequipment operation