常见问题Frequently Asked Questions
关于 FDA 注册、美国代理人与我们服务方式，大家最常问的都在这里。The most-asked questions about FDA registration, US Agents, and how we work — answered here.
FDA 注册和 FDA 认证是一回事吗？Is FDA registration the same as FDA certification?
不是，这是最常见的误解。FDA 注册（registration）是企业向 FDA 登记备案；FDA 认证 / 批准（approval / clearance）是 FDA 对产品安全有效的审查结论。
做了注册 ≠ 产品被 FDA“认证”了。市面上售卖的“FDA 认证证书”多为误导性文件，没有法律效力。
签约任何服务前，先确认对方说的是注册还是批准——我们会在咨询时把这条讲清楚。
No — this is the most common misunderstanding. FDA registration means a company enrolls with FDA; FDA approval / clearance is FDA's review conclusion about a product's safety and effectiveness.
Being registered ≠ being “certified” by FDA. Most “FDA certificates” sold online are misleading documents with no legal force.
Before signing with anyone, confirm whether they mean registration or approval — we make this clear in every consultation.
境外企业一定要指定美国代理人吗？Must a foreign company 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 的联络人。
美国代理人负责接收 FDA 的函件与通知，并在紧急情况下配合 FDA 联系企业。我们常驻美国，可长期担任。
Yes. Foreign food, cosmetics (MoCRA), medical device, and drug companies must all designate a US-based agent (US Agent) as FDA liaison when registering.
The US Agent receives FDA correspondence and helps FDA reach the company in emergencies. We are US-based and serve long-term.
食品设施注册多久续期一次？How often must food facilities renew registration?
每偶数年续期一次，窗口为 10 月 1 日至 12 月 31 日。2026 年是续期年，窗口为 2026-10-01 至 2026-12-31。
未按时续期会被从 FDA 注册库中除名，影响后续清关。我们的年费客户会收到提前提醒并由我们代办。
Every even-numbered year, October 1 – December 31. 2026 is a renewal year: the window is Oct 1 – Dec 31, 2026.
Missing renewal means removal from FDA's registry, which can hold up customs clearance. Our annual clients get advance reminders and full handling.
化妆品在美国销售需要 FDA 批准吗？Do cosmetics need FDA approval to sell in the US?
不需要上市前批准，但 MoCRA（2022）要求企业完成设施注册与产品列名，FDA 已从 2024 年 7 月起正式执法。
此外企业须保证产品安全（safety substantiation）、标签合规，并在 15 个工作日内报告严重不良事件。
No premarket approval is required, but MoCRA (2022) mandates facility registration and product listing — FDA has enforced this since July 2024.
Companies must also ensure product safety (safety substantiation), compliant labeling, and report serious adverse events within 15 business days.
一类医疗器械需要做 510(k) 吗？Does a Class I medical device need a 510(k)?
多数一类器械豁免 510(k)，但“豁免”不等于零申报：企业注册、产品列名、美国代理人、UDI 该做的都不能少。
部分二类器械也豁免 510(k)，多数二类需要。拿不准先做分类判定——分错类代价很大。
Most Class I devices are 510(k)-exempt — but “exempt” doesn't mean “no filings”: establishment registration, device listing, US Agent, and UDI are all still required.
Some Class II devices are also exempt; most Class II need a 510(k). When in doubt, classify first — misclassification is costly.
药品企业注册与列名有哪些时限？What are the drug registration & listing deadlines?
按 21 CFR Part 207：开始相关业务后 5 天内完成企业注册；初始注册后 3 天内完成药品列名；每年 10 月 1 日–12 月 31 日做年度更新与认证；每年 6 月、12 月复核列名信息。
FDA 对时限卡得很严，逾期可能收到警告信或面临合规行动。
Under 21 CFR Part 207: register the establishment within 5 days of beginning operations; list drugs within 3 days of initial registration; complete the annual update and certification every Oct 1 – Dec 31; review listing information each June and December.
FDA enforces these deadlines strictly — missing them can trigger warning letters or compliance action.
NDC 12 位新规对我有影响吗？Does the 12-digit NDC rule affect me?
如果你做药品（含 OTC）出口美国，有影响。FDA 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。
ERP、标签系统、条码（一维/二维）、DSCSA 主数据都要规划升级。现在开始准备，时间充裕；拖到过渡期会很被动。
If you export drugs (including OTC) to the US, yes. FDA's 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.
ERP, label systems, barcodes (linear/2D), and DSCSA master data all need upgrade planning. Start now while there's time; waiting until the transition will be painful.
你们能保证注册通过吗？Can you guarantee a successful registration?
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：品类与路径判定准确、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，把成功率做到最高。凡是承诺“包过”的，建议直接拉黑。
No — and no honest provider can; the decision rests with FDA.
What we do guarantee: accurate category and pathway determination, complete and compliant submissions, and prompt professional handling of every FDA response — maximizing your chance of success. Anyone promising “guaranteed approval” should be avoided.
费用是怎么计算的？How are fees calculated?
我们的服务费按项目定制：先评估你的产品与需求，再给书面分项报价，明确包含与不包含的内容。
FDA 官费、第三方测试费实报实销，不加价。官网不挂完整价目表——因为每个项目范围确实不同。
Our service fees are customized per project: we evaluate your product and needs first, then quote in writing item by item — what's included and what's not.
FDA official fees and third-party testing are passed through at cost, no markup. We don't post a full price list — because every project's scope genuinely differs.
整个流程一般要多久？How long does the whole process take?
看品类：食品设施注册、化妆品 MoCRA 注册列名通常以周计；一类/二类豁免器械注册列名也较快；510(k) 全案则以月计，取决于比对器械与测试范围。
咨询时我们会按你的具体情况给时间预估，并写进方案。
It depends on the category: food facility registration and MoCRA cosmetics registration/listing are typically counted in weeks; Class I / 510(k)-exempt device registrations are also quick; a full 510(k) takes months, depending on the predicate and testing scope.
During consultation we give a timeline estimate for your specific case, in writing.
收到 FDA 警告信 / 货物被扣怎么办？What if I get an FDA warning letter / my shipment is detained?
先别慌，也别拖：警告信与扣货都有回复时限，越早专业介入，解决成本越低。
我们提供专项应对：原因分析、英文回复函撰写与提交、整改计划（CAPA）指导、进口警报移除支持。先把收到的文件发给我们评估。
Don't panic — but don't delay either: warning letters and detentions have response deadlines, and earlier professional intervention means lower resolution cost.
We handle it as a dedicated project: root-cause analysis, English response letters, CAPA guidance, and import alert removal support. Send us what you received for an evaluation.
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邮件联系，中文 / English 均可，一般 1–2 个工作日内回复。Email us in Chinese or English; we typically reply within 1–2 business days.