FDA 注册，一站式交给美国本土团队FDA Registration, Handled End-to-End by a US-Based Team
我们为进入美国市场的境外企业提供 FDA 注册、美国代理人（US Agent）与持续合规服务——中英双语沟通，流程透明，响应及时。We help foreign companies entering the US market with FDA registration, US Agent service, and ongoing compliance — bilingual communication, transparent process, responsive support.
覆盖 FDA 四大监管品类Covering All Four FDA-Regulated Categories
食品、化妆品、医疗器械、药品——每个品类都有对应的注册路径与合规要求，点击查看具体服务内容。Food, cosmetics, medical devices, drugs — each category has its own registration pathway and compliance requirements. Click through for details.
食品与膳食补充剂Food & Dietary Supplements
食品设施注册、续期，美国代理人，标签合规（Nutrition Facts / Supplement Facts），低酸·酸化罐头 FCE + SID。Food facility registration & renewal, US Agent, labeling compliance, FCE + SID for low-acid / acidified canned foods.
化妆品 MoCRACosmetics · MoCRA
MoCRA 设施注册与产品列名、美国代理人、标签与成分合规、安全佐证，帮你跟上 FDA 执法节奏。MoCRA facility registration & product listing, US Agent, labeling & ingredient compliance, safety substantiation.
医疗器械Medical Devices
一类 / 二类（510(k) 豁免）企业注册与产品列名、美国代理人、UDI / GUDID，510(k) 全案评估与申报支持。Class I / Class II (510(k)-exempt) establishment registration & listing, US Agent, UDI / GUDID, and 510(k) submission support.
OTC 与药品OTC & Drugs
药品企业注册与药品列名（21 CFR Part 207）、NDC 码、OTC 专论路径、DSCSA 合规，美国代理人服务。Drug establishment registration & drug listing (21 CFR Part 207), NDC numbers, OTC monograph pathway, DSCSA compliance, US Agent.
项目制服务Project Services
510(k) 全案、标签审核、FDA 扣货 / 警告信应对、DMF 等——按项目评估，单独定制报价。510(k) submissions, label reviews, FDA detention / warning letter response, DMF — scoped per project with customized quotes.
美国代理人服务US Agent Service
境外食品、化妆品、医疗器械、药品企业进入美国市场，法规要求指定美国代理人——我们常驻美国，可长期担任。Foreign food, cosmetic, device, and drug companies need a US Agent to enter the US market — we are US-based and available long-term.
人在美国，懂中国企业Based in the US, Fluent in Your Business
跨境合规最怕信息差：我们在美国本土递交、跟进，与 FDA 同一时区；用中文把每一步讲清楚。Cross-border compliance fails on information gaps. We file and follow up from within the US, in FDA's time zone — and explain every step in Chinese.
- ✓美国本土递交Filing from inside the US同一时区跟进 FDA 函件与系统状态，不让时差耽误事。Same time zone as FDA for correspondence and system updates — no delays from time differences.
- ✓中英双语全程Bilingual end-to-end中文讲方案、英文做申报，资料与函件双语对照，零误解。Strategy in Chinese, submissions in English, bilingual documentation — zero misunderstandings.
- ✓不只是注册一次Beyond one-time registration续期、年报、列名更新、法规变化提醒，持续陪跑。Renewals, annual reports, listing updates, regulatory change alerts — ongoing support.
- ✓诚实透明Honest and transparent不承诺“包过”、不混淆注册与认证；做不了的直接说，能做的写进方案。No “guaranteed approval” promises, no confusing registration with certification. If we can't do it, we say so.
我们为你做的What we handle for you
- 注册路径判定：先确认你的产品到底归 FDA 哪个品类、走哪条路径，避免走错路花冤枉钱。Pathway determination: confirm which FDA category your product falls into and the right pathway — avoid costly wrong turns.
- 资料清单与预审：按 FDA 要求逐项准备，中英双语核对后再递交。Documentation checklist & pre-review: prepared item by item to FDA requirements, checked bilingually before submission.
- 美国代理人（US Agent）：法规要求的境内联络人，我们长期担任。US Agent: the domestic contact required by regulation — we serve long-term.
- 递交后跟进：FDA 补件、问询、系统状态，全程盯到办结。Post-submission follow-up: FDA deficiencies, inquiries, and system status tracked through to completion.
四步走，从咨询到长期合规Four Steps, From Consultation to Long-Term Compliance
每一步都有书面确认，你随时知道进展到哪了。Written confirmation at every step — you always know where things stand.
需求评估Needs Assessment
了解你的产品、目标市场与时间计划，判定 FDA 监管品类与注册路径。We learn about your product, target market, and timeline, then determine the FDA category and registration pathway.
方案与报价Proposal & Quote
给出书面服务方案与分项报价，明确包含内容、周期与 FDA 官费。A written proposal with itemized quote — scope, timeline, and FDA official fees spelled out.
注册申报Registration & Filing
准备资料、双语核对、以美国代理人身份递交并跟进 FDA 反馈。Documents prepared, checked bilingually, filed as your US Agent, with FDA feedback handled.
持续合规Ongoing Compliance
续期提醒、年度更新、列名维护、法规变化通知，长期陪跑。Renewal reminders, annual updates, listing maintenance, regulatory change alerts — long-term partnership.
最近值得关注的 FDA 变化FDA Changes Worth Watching
法规在变，我们帮你盯着。下面是最新的几条动态解读。Regulations keep changing — we keep watch. Here are the latest highlights.
NDC 码 12 位新规终规发布FDA Finalizes 12-Digit NDC Format
2026 年 3 月终规：NDC 统一为 12 位（6-4-2），2033 年 3 月 7 日生效，7 年准备期 + 3 年过渡期。做药品出口的现在就该规划系统与标签升级。March 2026 final rule: NDC moves to a uniform 12-digit (6-4-2) format, effective March 7, 2033, with a 7-year preparation period plus a 3-year transition. Drug exporters should start planning system and label upgrades now.
查看详情Read more → 2026-10食品设施注册续期窗口开启Food Facility Registration Renewal Window Opens
2026 年是续期年：10 月 1 日至 12 月 31 日，所有美国及境外食品设施须完成两年一次的续期，逾期可能被除名影响清关。2026 is a renewal year: October 1 – December 31, all domestic and foreign food facilities must complete biennial renewal. Missing it risks removal from the registry and customs holds.
查看详情Read more → FY2027FDA 2027 财年官费更新FDA FY2027 User Fees Updated
510(k)：标准 $28,653 / 小企业 $7,163；器械企业年费 $13,785；OMUFA 药品设施费同步调整。申报前先确认当年费用标准。510(k): standard $28,653 / small business $7,163; device establishment annual fee $13,785; OMUFA drug facility fees adjusted. Always confirm the current-year fee schedule before filing.
查看详情Read more →先看看大家最常问的Start With the Most-Asked Questions
这三个问题，几乎每位新客户都会问到。Nearly every new client asks these three questions.
FDA 注册和 FDA 认证是一回事吗？Is FDA registration the same as FDA certification?
不是。FDA 注册（registration）是向 FDA 登记备案；FDA 认证 / 批准（approval / clearance）是对产品安全有效的审查结论，两者完全不同。市面上“FDA 认证证书”多为误导性说法，签约前务必分清。No. FDA registration means enrolling with FDA; FDA approval / clearance is a review conclusion about a product's safety and effectiveness — they are entirely different. Most “FDA certificates” sold online are misleading. Know the difference before you sign anything.
境外企业一定要指定美国代理人吗？Must foreign companies designate a US Agent?
是的。食品、化妆品（MoCRA）、医疗器械、药品的境外企业在 FDA 注册时，法规都要求指定一名位于美国境内的代理人（US Agent）作为 FDA 联络人。我们常驻美国，可长期担任。Yes. Foreign food, cosmetics (MoCRA), medical device, and drug companies are all required to designate a US-based agent (US Agent) as FDA liaison when registering. We are US-based and serve long-term.
你们能保证注册通过吗？Can you guarantee approval?
不能，任何诚实的服务商都不能——审批权在 FDA。我们能保证的是：路径判定准确、资料按 FDA 要求完整合规地准备与递交、FDA 的每一次反馈都及时专业地跟进，把通过率做到最高。No — and no honest provider can; the decision rests with FDA. What we do guarantee: accurate pathway determination, complete and compliant submissions, and prompt professional handling of every FDA response — maximizing your chance of success.
不确定你的产品要走哪条路？Not sure which pathway your product needs?
把产品情况发给我们，帮你判定品类、路径与合规清单——咨询免费，报价定制。Send us your product details and we'll map the category, pathway, and compliance checklist — free consultation, customized quotes.