大兴庞各庄北京医疗器械三类经营许可证可全包代办专业快捷包下证
请人提交申请资料到相关部门;
(2)相关部门受理申请人的申请;
(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;10、申请材料应完整、清晰、签字,并逐份加盖公章,
所以很少有经销商有销售三类医疗器械的资格。
4、去工商局办理增项,是需要带着工商局的工作人员来查看库房的,你zuihao把库房收拾一下,然后领取《医疗器械经营企业许可申请表》并填写,并把企业相关资质全部带上,还需要带上质量人员的相关资料。
5、三类医疗器械经营许可证,需要直接去市级人民政府食品药品监督管理部门办理,在接受资料后的30天内进行审核
ass 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; 10, the application materials shall be complete, clear and signed, and stamped with the official seal, so few distributors are qualified to sell Class III medical devices.4, go to the Industrial and commercial Bureau for additional items, is the need to take the staff of the Industrial and commercial Bureau to check the warehouse, you had better clean up the warehouse, and then get the "medical device business enterprise license application form" and fill in, and bring all the relevant qualifications of the enterprise, but also need to bring the relevant information of quality personnel.5. The business license of Class III medical devices shall be handled directly by the food and drug supervision and administration department of the municipal people's government, and shall be reviewed within 30 days after receiving the data