西城阜成门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
(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;
(五)产品说明书以及标签样稿;4、工商行政管理部门出具的《企业名称预先
8、申请材料真实性的自我保证声明应由法定代表人签字并加盖企业公章,如无公章,则须有法定代表人本人签字或签章。
9、凡申请材料需提交复印件的,申请人(单位)须在复印件上注明“此复印件与原件相符”字样或者文字说明,注明日期,加盖单位公章;个人申请的须签字或签章。
submitted: (1) product risk analysis data; (2) product technical requirements; (3) product inspection report; (4) clinical evaluation data; (5) product description and label samples; 4. Enterprise name in advance issued by the administrative department for industry and commerce 8. The self-guarantee statement of the authenticity of the application materials shall be signed by the legal representative and affixed with the official seal of the enterprise. If there is no official seal, there shall be the signature or signature of the legal representative himself. 9. If the application materials need to be submitted, the applicant (unit) shall indicate the words "the copy" or the original, indicate the date and stamp the official seal of the unit; the individual application shall be signed or signed.