FDA对于美国代理人的解释也可以参考看一下网站的原文: Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S. agent) for that establishment. Information about a foreign establishment’s U.S. Agent is submitted electronically using the FDA Unified Registration and Listing System (FURLS system) and is part of the establishment registration process. Each foreign establishment may designate only one U.S. agent. The foreign establishment may also, but is not required to, designate its U.S. agent as its official correspondent. The foreign establishment should provide the name, address, telephone and fax numbers, and e-mail address of the U.S. agent. The U.S. agent identified will be required to complete an automated process to confirm that they have agreed to act as the U.S. agent. The automated process will forward an email verification request to the U.S. agent. They will be re to confirm her/his consent to act as a representative/liaison on behalf of the foreign establishment. If the U.S. agent denies consent (or does not respond within 10 business days), the Official Correspondent/Owner Operator of the foreign establishment will be notified and must designate a new U.S. agent to satisfy the regulatory obligation.
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FDA注册的流程 1)提供贵公司产品信息,我司为你进行产品类别判定并确定申请路径; 2)贵公司提供公司信息和产品信息,中英文信息,依据我司提供的申请表格式; 3)签署合约,同时美国代理人协议签署和生效; 4)我司协助申请贵公司支付美金到美国FDA; 5)我司提交注册申请资料给美国FDA审批; 6)注册审批完成,获得批准号码; 7)我司颁发证书; 8)次年开始进行年度更新注册。
![FDA510K认证](http://static.11467.com/img/lazy.gif)
每年更新FDA 要求: • 1) 注册和登记每年要更新一次(更新时间是:10月1号到12月31号 • 2) 要随时通知FDA注册和登记内容的变化。 – II 类产品,在进行设施登记和器械注册后,还需递交“上市前通知” 即510(K)申请。只有个别产品510(K) 豁免。
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我公司办理: 1. 美国代理人、FDA器械注册、FDA510K、FDA QSR820体系, 2. FDA QSR820验厂及整改、FDA警告信应对&RED LIST REMOVAL 3. TUV//NQA机构的:器械CE认证(93/42/EEC)、体外诊断器械CE认证(98/79/EC) 4.ISO9001:二015体系认证与版本升级、ISO13485:二016体系认证与版本升级 5.欧盟授权代表(EC-REP:representative in the EU)、英国MHRA器械注册 6. CFS 欧盟自由销售证,中国医药进出口商会自由销售证书 7. GMP认证、ISO22716 GMPC验厂, 英国BRC认证咨询,BSCI验厂 8. 灭菌验证方案设计和报告编制,器械欧盟标准检测,企业标准编制, MSDS编制服务 9. 口罩NELNSON(尼尔森)检测:(EN 14683检测、BFE检测,VFE检测、PFE检测) 10. 手术衣EN13795测试、防护服type5/6 认证、PPE认证咨询(89/686/EC个人防护指令)