REGISTRATION · PRODUCT CERTIFICATION
US FDA Registration
Exporting food, drugs, devices or cosmetics to the United States means registering with the US FDA and, for food, appointing a US Agent. We handle your FDA registration so your shipments clear US customs.
- 3–10 days
- turnaround
- Biennial
- renewal
- US market
- required
- REGULATOR
- US Food & Drug Administration
- APPLIES TO
- Food · drugs · devices · cosmetics
- TIMELINE
- 3–10 working days
- RENEWAL
- Biennial (food facilities)
- ALSO NEEDS
- US Agent (for food)
Quick facts
01 · OVERVIEW
What US FDA registration covers
Facilities that manufacture, process, pack or store food, drugs, medical devices or cosmetics for the US market must register with the US FDA. Food facilities also need a US Agent and, per shipment, prior notice. Registration is what lets your products enter the United States.
WHEN YOU NEED IT
- Exporting food or beverages to the US.
- Exporting drugs, devices or cosmetics to the US.
- Appointing a required US Agent.
- Meeting US importer requirements.
02 · OUR SERVICE
What’s included when we handle it
A done-for-you certification — we take it from assessment to an issued certificate.
- Applicability assessment
- Documentation & testing liaison
- Application filing
- Certificate / licence issued
- Label & compliance guidance
- Renewals & surveillance
03 · CHECKLIST
Documents you’ll need
Have these ready and we can move fast. Missing something? We’ll tell you up front.
01Facility details
Name, address and activities.
02Product details
Categories exported to the US.
03US Agent details
For food facilities.
04DUNS number
Facility identifier (if applicable).
05Business proof
Company registration.
06Contact details
Responsible person.
04 · HOW IT WORKS
The process, step by step
No jargon, no chasing — here’s exactly how we take it from start to certified.
Assess applicability
We confirm which certification your product needs.
Prepare docs & testing
We arrange documentation and lab testing.
File the application
We submit to the certifying body.
Audit / review
We support any inspection or review.
Certificate issued
Your certification is granted and handed over.
05 · KEEP GOING
Certifications & registrations that pair with this
Most businesses need a few of these together — we can set them up in one go.
06 · FAQ
US FDA Registration — your questions
Straight answers on eligibility, timeline and what to expect.
Who needs US FDA registration?
Any facility making, processing, packing or storing food, drugs, devices or cosmetics for the US market. We confirm your category and register you.
Do I need a US Agent?
TODO — this answer is collapsed in the Figma design and needs real copy.
How often must I renew?
TODO — this answer is collapsed in the Figma design and needs real copy.
How long does registration take?
TODO — this answer is collapsed in the Figma design and needs real copy.
GET STARTED
Register with the US FDA and enter the US.
We’ll complete your FDA registration and US Agent set-up so your food, drugs or devices clear US customs.