All Posts

Published by US Compliance Agent LLC Foreign sellers on Amazon U.S. are getting blocked at a higher rate in 2026 than at any point in the last three years. The flag is almost always the same: missing or invalid FCC SDoC contact information. This isn't random enforcement. Three regulatory and platform-level changes have converged, and the result is that listings which were fine in 2024 are now getting pulled. Here's what's actually changing and what to do about it. What's Driv

Published by US Compliance Agent LLC If you're listing a consumer electronic product on Amazon and you're staring at the FCC Radio Frequency Emission Compliance form right now, this guide walks you through every field — what to enter, what to leave blank, and how to get your listing live the same day. This guide is for the SDoC pathway (Supplier's Declaration of Conformity) under FCC Part 15, Subpart B. If your product has an FCC ID, see our FCC ID vs. SDoC explainer first to

Published by US Compliance Agent LLC If you sell consumer electronics on Amazon, you've probably hit a wall that looks like this: Amazon's listing form asks for "FCC Radio Frequency Emission & Authorization Status" with two options — FCC Certification with an FCC ID, or a Supplier's Declaration of Conformity (SDoC). For most foreign sellers, this is the first time they've seen these terms. And picking the wrong one can block your listing for weeks while you sort out documents

由 US Compliance Agent LLC 发布 如果您是一家被要求为FDA、FCC或其他联邦机构指定美国代理人的外国制造商，您最先想知道的问题之一可能是：这要花多少钱？ 答案因机构、供应商以及代理人服务是独立的还是与咨询捆绑在一起而有很大差异。本指南解析真实的定价情况，帮助您做出明智的决定。 简短回答 独立美国代理人服务——您获得代理人指定、美国地址、电话号码和通信转发，不包含任何咨询或注册协助——通常费用在 149至400美元/年 之间，具体取决于机构垂直领域。 捆绑服务——代理人指定与监管咨询、注册协助、标签审查、GMP审计和其他附加服务打包在一起——费用可达 500至1,500美元甚至更多/年 。 问题不仅仅是"花多少钱"，而是"我到底需要什么？" 按机构分类的价格 FDA / MoCRA 化妆品美国代理人 市场价格范围： 199–1,500美元/年 Registrar Corp和Biorius等大型监管咨询公司收费500至1,500美元以上，但他们的定价包含捆绑服务：注册协助、标签审查、监管咨询、GMP指导和持续合规支持。这些

由 US Compliance Agent LLC 发布 如果您的公司在美国以外的地区生产电子设备并希望在美国市场销售，有一项监管要求容易被忽视但绝不可跳过：指定FCC美国代理人。 美国联邦通信委员会（FCC）要求寻求设备授权的外国制造商指定一名位于美国的代理人，以代表其接收法律文件和通信。这一要求根据47 CFR 2.911(d)(7)编纂在法规中——没有它，您的FCC申请将不被接受。 本文解释FCC美国代理人的要求、谁需要指定代理人、代理人的职责，以及如何完成指定。 什么是FCC美国代理人？ FCC美国代理人是位于美国境内的个人或公司，被指定代表申请FCC设备授权的外国实体接收法律文件送达和通信。 当外国制造商提交产品进行FCC认证——确认电子设备符合FCC射频发射和干扰标准的过程——FCC需要一种方式在出现问题时联系美国境内的人。美国代理人就是这个角色。 该要求见于47 CFR 2.911(d)(7)，规定外国实体的申请必须包含指定的美国代理人，用于法律文件送达。 谁需要FCC美国代理人？ 任何位于美国以外申请FCC设备授权的公司或个人都需

由 US Compliance Agent LLC 发布 如果您在美国以外的地区生产化妆品并在美国市场销售，有一项监管要求您不能忽视：指定一名MoCRA美国代理人。 2022年通过的《化妆品现代化监管法案》（MoCRA）是86年来美国化妆品监管领域最重大的改革。根据该法案，所有为美国市场生产或加工化妆品的外国工厂必须在FDA注册，并指定一名位于美国的代理人。 本文解释什么是MoCRA美国代理人、谁需要指定代理人、代理人的职责是什么，以及如何快 速完成指定。 什么是MoCRA美国代理人？ MoCRA美国代理人是位于美国境内的个人或公司，被指定为外国化妆品工厂与FDA之间的官方沟通联络人。 当外国制造商在FDA注册其化妆品工厂时，FDA需要一个在美国的联系人来处理官方通信。美国代理人就是这个角色——接收并转发FDA发给您工厂的所有通信。 这是MoCRA的强制性要求。没有美国代理人，您的工厂注册无法完成——这意味着您的产品可能在美国边境被拒绝入境。 谁需要MoCRA美国代理人？ 如果以下任何情况适用于您，您需要一名美国代理人： 外国化妆品制造商。 ..

由 US Compliance Agent LLC 发布 中国是全球最大的化妆品生产基地。数以千计的中国企业为美国市场生产护肤品、彩妆、护发产品和个人护理产品——通过美国品牌合作、亚马逊、品牌官网或零售渠道进入美国市场。 2022年通过的《化妆品现代化监管法案》（MoCRA）彻底改变了这些企业的合规要求。如果您的中国工厂为美国市场生产化妆品，您现在必须遵守2022年之前不存在的FDA强制性要求——包括指定美国代理人（U.S. Agent）。 本指南专为需要应对MoCRA合规要求的中国化妆品制造商编写。 MoCRA对中国制造商的要求 MoCRA适用于所有为美国市场生产或加工化妆品的外国工厂。对于中国制造商，主要义务包括： 工厂注册。 您的生产工厂必须通过FDA的Cosmetics Direct门户网站（direct.fda.gov）进行注册。每个为美国市场生产、加工、包装或储存化妆品的工厂都需要单独注册。 指定美国代理人。 作为外国工厂，您必须在注册时指定一名位于美国的代理人。FDA通过该代理人与您的工厂进行沟通。没有美国代理人，您的注册无法完

Published by US Compliance Agent LLC When foreign manufacturers learn they need a U.S. Agent for FDA, FCC, or NHTSA compliance, the first instinct is often: "Can my U.S. importer or distributor just do this?" The answer is yes — technically. Any person or company located in the United States can serve as your U.S. Agent. There is no regulation that prohibits your importer from filling this role. But just because they can does not mean they should. Here are the practical reaso

Published by US Compliance Agent LLC FDA's Cosmetics Direct portal is the electronic system where foreign cosmetics manufacturers register their facilities and list their products under MoCRA. If you are in the middle of the registration process and need clear, step-by-step instructions, this guide walks you through exactly what to do. Before You Start Make sure you have the following ready before you log into Cosmetics Direct: Your FEI number. An FDA Establishment Identifie

Published by US Compliance Agent LLC You have registered your foreign facility with FDA, designated a U.S. Agent, and listed your products. Everything is in compliance. Then one day, FDA sends a letter to your U.S. Agent. What happens next depends entirely on what kind of agent you chose. This article walks through the most common types of FDA correspondence your U.S. Agent will receive and explains why the speed and quality of your agent's response matters. The Most Common T

Published by US Compliance Agent LLC China is the world's largest exporter of cosmetics and personal care products to the United States. Thousands of Chinese manufacturing facilities produce skincare, haircare, makeup, nail products, fragrances, and other cosmetics that end up on American shelves — through Amazon, direct-to-consumer websites, U.S. brand partnerships, and traditional retail distribution. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) changed the

Published by US Compliance Agent LLC One of the first questions foreign manufacturers ask when they learn about the U.S. Agent requirement is: how much does it cost? The answer depends on which agency you need an agent for, what services are included, and whether you are buying a standalone agent designation or a bundled consulting package. This guide breaks down the real pricing landscape so you can make an informed decision. The Short Answer For a standalone U.S. Agent desi

Published by US Compliance Agent LLC If you are a foreign company entering the U.S. market, you have probably encountered three terms that sound similar but mean very different things: U.S. Agent, Registered Agent, and virtual mailbox. Confusing them can lead to compliance gaps, wasted money, or both. This article explains each one, what it does, who needs it, and why they are not interchangeable — including exactly how strict each federal agency is about PO boxes, virtual ma

Published by US Compliance Agent LLC If you manufacture products outside the United States and sell them into the American market, there is a good chance you are required to designate a U.S.-based agent or contact for one or more federal regulatory agencies. But the requirements vary significantly depending on what you make. This guide cuts through the confusion. Find your product type below and learn exactly which U.S. Agent designation applies to you, which agency requires

Published by US Compliance Agent LLC Starting July 8, 2026, the U.S. Consumer Product Safety Commission (CPSC) will require all importers of regulated consumer products to electronically file Certificates of Compliance with U.S. Customs and Border Protection (CBP) at the time of entry. This is a major change in how imported consumer products are screened at U.S. ports — and it directly affects every foreign manufacturer whose products are sold in the American market. This art

Published by US Compliance Agent LLC If your company manufactures or exports chemical substances outside the United States for sale into the American market, you may be required to designate a U.S.-based agent under the Toxic Substances Control Act (TSCA). The Environmental Protection Agency (EPA) administers TSCA and uses it to regulate the import, manufacture, processing, and distribution of chemical substances in the United States. This article explains the TSCA agent requ

Published by US Compliance Agent LLC If your company manufactures vehicles, vehicle equipment, or automotive components outside the United States and wants to sell them in the American market, you are required to designate a U.S. Agent. This requirement is established under 49 CFR §551.45 and administered by the National Highway Traffic Safety Administration (NHTSA), a division of the U.S. Department of Transportation (DOT). This article explains who needs an NHTSA/DOT U.S. A

Published by US Compliance Agent LLC Choosing a U.S. Agent is one of the first compliance decisions foreign manufacturers face when entering the American market. Whether you need an agent for FDA registration, MoCRA cosmetics compliance, FCC equipment authorization, or e-commerce marketplace requirements, the choice of provider matters more than most companies realize. A responsive, reliable U.S. Agent keeps your regulatory communications flowing smoothly. A poor one can mean

Amazon INFORM Act: U.S. Agent Requirements for Foreign Sellers Published by US Compliance Agent LLC If you sell products on Amazon from outside the United States, you have likely encountered requirements related to the INFORM Consumers Act. This federal law, which went into effect on June 27, 2023, requires online marketplaces like Amazon to collect and verify certain information about high-volume third-party sellers — and for foreign sellers, that includes having a verifiabl

Published by US Compliance Agent LLC If you manufacture medical devices outside the United States and sell them into the U.S. market, you are required to register your establishment with the FDA and designate a U.S. Agent. This requirement has been in place for years under 21 CFR Part 807, and it applies to every foreign medical device establishment — regardless of the risk classification of your devices. This guide covers who needs an FDA U.S. Agent for medical devices, what