Two Sides of FDA Compliance
Many businesses — especially those new to the U.S. market — confuse two fundamentally different regulatory processes:
- Importing into the U.S.: Getting your foreign-made products into the U.S. market (requires FDA registration, U.S. Agent, labeling compliance)
- Exporting from the U.S.: Getting a U.S. company's products into foreign markets (may require FDA export certificates for the destination country)
These are completely separate processes with different requirements, different FDA forms, and different compliance obligations. Confusing them leads to wasted time, money, and potential regulatory violations.
Importing FDA-Regulated Products into the United States
If you are a foreign manufacturer who wants to sell your products in the U.S. market, you are dealing with import compliance. Requirements include:
- FDA facility registration (food, drugs, devices, cosmetics)
- Designating a U.S. Agent
- FDA-compliant labeling
- Prior Notice for food shipments (the FDA must receive advance notification before each food shipment enters the U.S.)
- Compliance with applicable GMP, safety, and testing standards
- Customs entry filing and FDA entry review at the port of entry
Exporting FDA-Regulated Products from the United States
If you are a U.S. manufacturer who wants to sell your products in foreign markets, those foreign governments may require proof that your products are legal and compliant in the U.S. This is where FDA export certificates come in.
Key export certificate types:
- Certificate for Foreign Government (CFG): For drugs and biologics, certifying FDA regulatory status
- Certificate to Foreign Government: For medical devices, certifying 510(k)/PMA status
- Certificate of Free Sale (CFS): General document confirming the product is legally marketed in the U.S.
- Good Manufacturing Practice Certificate: Certifying that a drug facility meets FDA GMP standards
Can a Foreign Manufacturer Need Both?
Yes — and this is where it gets complex for global manufacturers. Consider this scenario:
Example: Sri Lankan Food Manufacturer
A food company in Sri Lanka wants to export to the U.S. AND also export to the UAE. The UAE requires a Certificate of Free Sale from the U.S. market as proof that the product is accepted in the U.S.
This company needs:
- ✅ FDA food facility registration (to export to the U.S.) — import compliance
- ✅ Certificate of Registration from Regovant (as proof of FDA compliance) — satisfies UAE's CFS requirement
The Regovant Certificate of Registration often satisfies the CFS requirement for many destination countries, making it doubly valuable.
Key Differences at a Glance
Import Compliance vs. Export Certificates
- Purpose: Import = right to sell in U.S. | Export = proof of U.S. compliance for foreign markets
- Who needs it: Import = foreign manufacturers | Export = U.S. manufacturers (or foreign manufacturers leveraging their U.S. registration)
- Issued by: Import = not "issued" — it's a compliance status | Export = FDA issues certificates
- Renewal: Import registration requires periodic renewal | Export certificates valid for the period stated on the document
- Cost: Import = registration fees + U.S. Agent fees | Export = FDA certificate fees + possible apostille fees
Prior Notice: A Special Import Requirement
For food products specifically, the FDA requires Prior Notice — advance notification before every food shipment arrives at a U.S. port of entry. Prior Notice must be submitted electronically via the FDA's Prior Notice System Interface (PNSI) or through the CBP's Automated Broker Interface (ABI).
Prior Notice must be submitted:
- At least 2 hours before arrival for food transported by road
- At least 4 hours before arrival for food transported by air or land from Canada/Mexico
- At least 8 hours before arrival for food transported by ocean vessel
Failure to submit Prior Notice or submitting incorrect Prior Notice can result in shipment refusal.