SUNGO TECHNICAL SERVICE LLC是美国的专门从事法规技术服务的集团公司，在英国注册为SUNGO GROUP COMPNAY LIMITED，在中国注册为上海沙格企业管理咨询有限公司。SUNGO集团凭借网络和队伍为客户提供法规性服务，在器械行业尤为专长。 选择SUNGO，不是选择了一次性的合作伙伴，而是选择了一个长期的技术支持的战略伙伴。 选择了SUNGO作为美代的您可以享受到如下星级服务： 1. FDA注册的日常维持，更新； 2. FDA新动态的时间告知及建议； 3. 随时为您提供与FDA注册和上市后监管等相关的事务的处理意见； 4. 可代表您回答您美国客户的相关FDA问题（英文邮件，英文电话会议均可）； 5. 接受FDA验厂时，以优惠的价格提供QSR820、审核经验传授及全程英语陪审
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 requested 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.
FDA 化妆品注册怎么做？ FDA化妆品注册（138电181话046微17信） • 1/ 化妆品企业注册可以在出口美国之前或者出口之后（30天内）； • 2/ 化妆品产品注册需要有1000美金的出口之后，实际上FDA无法核对； • 3/ Can I file formulations in the VCRP for products that are considered drugs but also have a cosmetic function? 对于药品有化妆品功能的是否可以做化妆品注册？ • Yes, products that are considered drugs in the United States, such as sunscreens, but also make cosmetic type claims, such as moisturizing, can be filed in the VCRP. • 4/ 可以进行化妆品注册，这并不能豁免其需要满足药品的相关要求的职责。
关于SUNGO公司 SUNGO是化的器械、食品企业法规技术服务商。 SUNGO包括三家公司，分别是位于美国的SUNGO Technical Service Inc.，位于英国的SUNGO Certification Company Limited和上海沙格企业管理咨询有限公司。 SUNGO的业务起源于2006年，在器械行业开展法规技术服务达10年之久，截止到目前累积客户超过1500家。其中包括很多业内的企业和上市企业，例如威高集团、恒安集团、暴龙眼镜、刚松股份、江苏鱼跃、河南羚锐等。 SUNGO始终追求支持、服务和客户满意。所有客户都有一对一的客服对接以保持经常性的联系，提供在线即时服务，针对贸易中存在的技术壁垒方面的问题提供的支持和解答。