Operations live · Mon–Sat 08:30–17:30 (UTC+8)运营中 · 周一至周六 08:30–17:30（北京时间） HQ HANGZHOU · CN总部 杭州 · 中国
info@8express.cn +86 571 8733 7165
M
Mile Global Logistics
8express.cn8express.cn · 应理国际物流
Track查询货件 Pre-assessment预约预评估
Lab inspection counter
/ FDA full-service · for 2026/ FDA 全流程 · 2026 新业务

Move regulated goods.
Without holding your breath
at the port. 把监管类货物运过去，
不必每次在港口屏住呼吸。

End-to-end FDA registration, labeling, Prior Notice, and detention support for supplements, cosmetics (MoCRA), food, pet food, and Class I–II medical devices — owned by one project manager from origin factory to Amazon shelf. 膳食补充剂、化妆品（MoCRA）、食品、宠物食品、I–II 类医疗器械的 FDA 注册、标签、Prior Notice 与扣货应对一站式服务 —— 一个项目经理从工厂跟到亚马逊货架。

Book free pre-assessment预约免费预评估 See the 6-step pipeline查看六步流程
100%FDA entries first-pass · 12moFDA 入境一次性放行 · 12 个月
68FDA entries this month本月 FDA 入境申报
6Steps, one project manager六个步骤，一位项目经理
30minFree pre-assessment免费预评估
/ Who this is for/ 适合谁

We're not a one-size-fits-all
compliance broker.我们不做"一刀切"
的合规代办。

Three buyer profiles drive most of our FDA work today. If your business looks like one of these, we already speak your dialect — the SKUs, the warning letters, the buyer reviews that get pulled.目前我们 FDA 业务的客户大致分三类。如果你的业务长得像其中之一，那我们已经熟悉了你的 SKU 节奏、警告信范式，以及那些会被亚马逊下架的买家评价。

Product category
Profile A · Supplements类型 A · 膳食补充剂

Vitamin / nutraceutical brand scaling Amazon US维生素 / 营养补充剂品牌，亚马逊美国站放量

Selling 20–200 SKUs across vitamins, sports nutrition, or herbal supplements. Already past $1M GMV, ready to invest in proper compliance.维生素、运动营养或草本类 20–200 个 SKU，年 GMV 100 万美金以上，已开始重视合规投入。

Disease claim language flagging shipments疾病声明措辞触发扣货 Supplement Facts panel rejections补充剂事实表（Supplement Facts）被拒 No US Agent of record没有美国代理人
Product category
Profile B · Cosmetics类型 B · 化妆品（MoCRA）

DTC skincare or color brand entering US under MoCRADTC 护肤或彩妆品牌，在 MoCRA 下进入美国

Brand has facility registration but skipped product listing or Responsible Person — newly enforceable under MoCRA from 2024.品牌完成了工厂注册，但漏掉了产品列名或责任人指派 —— MoCRA 自 2024 年起开始执法。

Responsible Person not yet designated尚未指定 Responsible Person Product listing incomplete产品列名不完整 Adverse-event recordkeeping unclear不良事件记录流程不清晰
Product category
Profile C · Food & device类型 C · 食品 / 器械

Pet food, packaged food, or Class I–II device manufacturer宠物食品、包装食品或 I–II 类医疗器械制造商

Annual FDA registration is already in place, but Prior Notice, labeling, and detention response are handled ad hoc by the freight forwarder.已完成 FDA 年度注册，但 Prior Notice、标签、扣货应对都是货代临时处理。

Prior Notice errors causing exam holdsPrior Notice 错填导致查验扣货 No detention playbook in place没有扣货应对预案 DUNS / UDI assignment unclearDUNS / UDI 编码归属不清
/ The pipeline/ 完整流程

Six steps,
and what you actually get
at each one.六个步骤，
每一步你实际
会拿到的东西。

Every stage produces a written deliverable in your shared workspace. No "we'll let you know how it went" — you see registration numbers, label proofs, and Prior Notice confirmations as they're issued.每一步都有书面交付物，放在你的共享工作空间里。没有"事情大概顺利"这种话 —— 注册号、标签印前样、Prior Notice 确认号，签发当天你就能看到。

01
Pre-assessment合规预评估

30-min call with our regulatory lead. We map your product category, intended use, target buyer, and current registration footprint.与监管负责人 30 分钟通话，梳理产品类目、用途、目标买家、当前注册现状。

You receive你会拿到 Risk-flag matrix by SKU按 SKU 拆解的风险等级矩阵 Registration gap report注册缺失项报告 Recommended scope & fee建议服务范围与费用
SLA时效1–2 BD
02
Registration & listing注册 · 列名

FDA establishment / facility registration, product listing, and US Agent of record designation. Annual renewal calendar set up on day one.FDA 工厂注册、产品列名、美国代理人指派。第一天就设置好年度续展提醒日历。

You receive你会拿到 Registration number + PINFDA 注册号 + PIN DUNS coordination (if needed)DUNS 编码协助（如需） Renewal calendar in shared workspace共享工作空间内续展日历
SLA时效5–10 BD
03
Labeling & documentation标签 · 文件审核

Pre-print review of every label your printer is about to run. Nutrition / Supplement Facts panels, ingredient order, allergens, COO, net quantity, claim language scan.在你的印刷厂下单之前，对每一版标签做合规审核：营养 / 补充剂事实表、配料表顺序、致敏原、原产国、净含量、声明措辞扫描。

You receive你会拿到 Annotated label review (PDF)标签批注审核稿（PDF） Pre-print compliant proof印前合规样张 Claim-language rewrite suggestions声明措辞改写建议
SLA时效3–7 BD
04
Origin pickup & shipping国内提货 · 头程运输

Origin factory pickup with FDA-aware QC. Ocean or air booking; temperature-controlled if needed for supplements or biologics.工厂提货时按 FDA 要求验货；安排海运或空运；补充剂或生物制品如需可走温控。

You receive你会拿到 Origin inspection photo report工厂验货照片报告 Booking confirmation + ETA订舱确认 + 预计到港 Temp log if applicable温控记录（如适用）
SLA时效14–25 D
05
Prior Notice & entryPrior Notice · 入境申报

Per-shipment Prior Notice filed before arrival. CBP entry filing, exam coordination, and immediate NoA response if flagged.货物到港前逐票 Prior Notice 申报；CBP 入境申报、查验配合，扣货时第一时间应对 NoA。

You receive你会拿到 Prior Notice confirmation #Prior Notice 确认号 Entry summary & bond detail入境概要 + 关税担保明细 NoA response packet (if needed)NoA 应对资料包（如需）
SLA时效2–5 BD
06
Last-mile to Amazon / DTC末端到亚马逊 / DTC

Trucking to FBA appointment, or storage at our US node for DTC fulfillment. Scan-on-arrival at Amazon DC, photo proof at our warehouse.卡派到 FBA 预约时段；或入我们美仓做 DTC 一件代发；亚马逊仓内扫描入库、自营仓照片确认。

You receive你会拿到 FBA shipment ID + scan logFBA Shipment ID + 扫描记录 Delivery photo at US WH (if DTC)美仓到货照片（DTC 模式） Per-unit reconciliation逐件入库对账
SLA时效3–7 D
/ Detention war stories/ 扣货实战记录

Three real holds.
Three releases.三起真实扣货，
三次成功放行。

Anonymized but unedited. These are the kinds of situations where a generic freight forwarder loses the shipment — and where a specialist team gets your goods released or reconditioned without re-export.匿名但未删改。这类场景下，普通货代会"丢单"或建议你退运 —— 而专业团队会争取放行或在地整改。

LAX · Supplement · 2025 Q4洛杉矶 · 膳食补充剂 · 2025 Q4

"Treats joint pain" — disease claim flag on a 2,400-bottle shipment"治疗关节疼痛" —— 2,400 瓶补充剂触发疾病声明扣货

A returning customer's new label copy went straight from the brand team to the printer. Shipment held at LAX on FDA disease-claim grounds. We submitted a reconditioning plan with on-site relabeling at our SAV node, released in 11 days.老客户的新标签从品牌部直接送印，到洛杉矶被以"疾病声明"扣留。我们提交了在 SAV 仓现场换标的整改方案，11 天内放行。

11d
Release time放行时长
0 bottles
Lost or re-exported退运或销毁
$3.4k
Reconditioning cost vs. $48k re-export整改费 vs. 退运 $48k
EWR · Cosmetics · 2025 Q3纽瓦克 · 化妆品 · 2025 Q3

MoCRA non-listed: cosmetics held pending Responsible Person designationMoCRA 未列名：化妆品在指定责任人前被扣

DTC skincare brand had facility registration but no product listing. We expedited listing, designated ourselves as Responsible Person of record, and submitted the bond. Released without re-export.DTC 护肤品牌完成了工厂注册但未列名。我们加急办理产品列名、指派我们作为责任人备案，并提交担保金，未退运直接放行。

8d
Release time放行时长
42
SKUs listed under MoCRAMoCRA 列名 SKU 数
0
Subsequent holds in 6 months后续 6 个月扣货次数
SAV · Pet food · 2025 Q2萨凡纳 · 宠物食品 · 2025 Q2

Prior Notice mismatch on a chilled pet food shipment冷藏宠物食品 Prior Notice 信息不符被查验

Original forwarder filed Prior Notice with the wrong product code. CBP held the entire reefer container at SAV. We refiled, coordinated cold-storage at port, and arranged private-lab testing to confirm safety. Released with no spoilage.原货代用了错误的产品代码做 Prior Notice，整柜在萨凡纳被扣。我们重新申报，协调港口冷库、安排第三方实验室检测，确认安全后放行，未发生变质损失。

5d
Cold-chain held冷链滞留
$0
Spoilage loss货损金额
100%
Goods released货物放行率

// Case details anonymized at client request. Reference letters available under NDA.

/ Packages/ 服务套餐

Three engagement shapes.
Pick the one that matches
where you are.三种合作方式，
挑一个匹配你
当前阶段的。

All quotes are all-in: no separate broker fee, no per-SKU listing surcharge, no Prior Notice add-on. Replaceable with your existing freight forwarder if you want to stage the transition.所有报价都是全包：不另收报关行费、不按 SKU 加收列名费、不按票加收 Prior Notice 费。可以保留现有货代做分阶段切换。

Single-shipment单票合规
from $1,800$1,800 起/ 票

One-off compliant shipment单次合规发货

For brands testing the US market with one or two shipments before committing to ongoing infrastructure.适合刚试水美国市场、还不需要长期注册基础设施的品牌。

  • Per-shipment Prior Notice逐票 Prior Notice 申报
  • Label spot-check (up to 10 SKUs)标签抽检（≤10 个 SKU）
  • CBP entry filingCBP 入境申报
  • Basic detention response基础扣货应对
Talk to us咨询
Registration + ongoing注册 + 持续 RECOMMENDED推荐
$8,500 + retainer$8,500 + 月费

Registration plus monthly partnership注册 + 月度合作

For brands committed to scaling US sales. We become your compliance + freight team for steady volume.适合长期布局美国市场的品牌。我们作为你的合规与货运团队，承接稳定货量。

  • FDA registration + listing + US AgentFDA 注册 + 列名 + 美国代理人
  • All-SKU label review + reprint advisory全 SKU 标签审核 + 再印建议
  • Unlimited Prior Notice filingsPrior Notice 申报不限次
  • Renewal calendar + monthly review续展日历 + 每月复盘
  • Dedicated project manager专属项目经理
  • Full detention & NoA support完整扣货 & NoA 应对
Book pre-assessment预约预评估
Registration-only仅注册
$6,500$6,500

Just the paperwork, your freight只做注册，货代你自留

For brands with a freight partner they like, who just need FDA registration done right and a US Agent of record.适合已经有满意货代、只需要把 FDA 注册做扎实并指派美国代理人的品牌。

  • FDA establishment registrationFDA 工厂注册
  • Product listing (up to 50 SKUs)产品列名（≤50 SKU）
  • US Agent designation美国代理人指派
  • Annual renewal reminder年度续展提醒
Talk to us咨询

// Pricing illustrative — actual quote depends on product category, SKU count, and shipment cadence.

/ FAQ/ 常见问题

Questions buyers ask
before signing.客户签约前
常问的问题。

Q.01

Are you an actual FDA-registered broker?你们真的是 FDA 备案的服务商吗？

Yes. We hold an in-house US licensed customs broker, are registered as a US Agent with FDA, and have ACE filer credentials. Documentation available under NDA before contracting.是。我们持有美国持牌报关行资质、已在 FDA 备案为美国代理人、拥有 ACE 申报权限。签约前可在 NDA 下提供资质文件。

Q.02

Do you handle the actual freight too, or just paperwork?你们做实际货运还是只做文件？

Both. Our cross-border logistics arm (10 years of FBA headway, ocean DDP, and US trucking) is the foundation. The FDA service line sits on top of that operations spine — which is exactly why we can act on detentions in hours, not weeks.都做。跨境物流业务（10 年 FBA 头程、海运 DDP、美国卡派）是底盘，FDA 服务线建在这套运营体系上 —— 这也是我们能用小时级而不是周级响应扣货的原因。

Q.03

Can we keep our existing freight forwarder?能保留现有货代吗？

Yes — pick the "Registration-only" package. We coordinate with your current forwarder on Prior Notice timing and entry filing. Many clients stage the transition: start with registration-only, move to full service after one season.可以 —— 选"仅注册"套餐。我们会与你现有货代协调 Prior Notice 时间和入境申报。很多客户做分阶段切换：先做注册，一个旺季后再转全托管。

Q.04

What categories do you NOT handle?哪些类目你们不接？

Prescription drugs (Rx), Class III medical devices, biologics, and tobacco / vapor products. For these we'll refer you to a specialist partner rather than take the engagement.处方药（Rx）、Class III 医疗器械、生物制品，以及烟草/电子烟。这些类目我们会推荐专业合作方，不接单。

Q.05

What happens if FDA holds our shipment?如果 FDA 扣货了怎么办？

For "Registration + ongoing" clients: included. Your project manager calls within 1 business hour with a response plan — sample-and-release, private-lab testing, reconditioning, or worst-case re-export. Each option costed before you decide."注册 + 持续"客户：包含在套餐内。1 个工作小时内项目经理会电话过来，给出方案 —— 抽样放行、第三方实验室检测、在地整改、或最坏情况退运。每个选项都会先算清楚成本再决策。

For single-shipment clients: handled at hourly rate with prior approval — historically 8–15 hours of work per detention.单票客户：按工时另行计费、需事先确认 —— 历史平均每起扣货 8–15 工时。

Q.06

How fast can you start?最快多快能开始？

Pre-assessment call: same week. Registration filing: within 5 business days of signed engagement. First compliant shipment: typically 3–4 weeks from kickoff, depending on category.预评估通话：当周。注册申报：签约后 5 个工作日内。第一票合规发货：通常签约后 3–4 周，依类目而定。

/ Start with a 30-minute call/ 从一通 30 分钟通话开始

Free pre-assessment.
No deck. Just your SKUs.免费预评估，
不发 PPT，只看你的 SKU。

Bring your product list, current registration status, and any recent FDA letters. We come back with a risk-flag matrix and a scope recommendation by end of week.把产品清单、当前注册状态、近期 FDA 函件带上。我们当周给出风险等级矩阵和建议服务范围。

Book the call预约通话 Email a specialist邮件联系顾问
Get a Quote立即询价 Contact联系