One Rule Applies to Every Country Equally
Regardless of your country, if your facility manufactures, processes, packs, or holds FDA-regulated products for the U.S. market, these three requirements apply universally.
🏭 FDA Facility Registration
Every foreign facility must register with the FDA before their first U.S. shipment. Registration is renewed annually or biannually depending on product type.
🏛️ U.S. Agent Designation
Every foreign facility must designate a U.S. Agent — a person or company physically located in the United States. No exceptions. No U.S. Agent = invalid registration.
📜 Certificate of Registration
Upon successful registration, your facility receives an FEI number and Certificate of Registration — required by U.S. importers and customs authorities.
FDA Registration for Vietnam Exporters
Vietnam is one of the fastest-growing sources of FDA-regulated exports to the United States — particularly seafood (shrimp, catfish, pangasius), coffee, processed foods, and an expanding medical device manufacturing sector. The U.S. is Vietnam's largest export market, with bilateral trade exceeding $110 billion annually.
Any Vietnamese facility manufacturing or exporting food, dietary supplements, medical devices, drugs, or cosmetics to the U.S. must register with the FDA and designate a U.S. Agent. Vietnam's seafood industry in particular is subject to frequent FDA import scrutiny — active compliance management is essential.
What Vietnamese exporters need:
- FDA Food Facility Registration + U.S. Agent (food, seafood, coffee, supplements)
- HACCP seafood compliance for aquaculture exports
- Prior Notice filing for every U.S.-bound shipment
- CDRH registration for medical device manufacturers
- MoCRA facility registration for cosmetics exporters
FDA Registration for Thailand Exporters
Thailand is a major exporter of processed food, seafood, canned goods, rubber gloves, medical devices, and dietary supplements to the United States. Thai food exports to the U.S. exceed $4 billion annually, with canned tuna, frozen seafood, and packaged snacks leading the way.
Important for Thai canned food exporters: Low-acid canned foods (LACF) require not only standard FDA Food Facility Registration but also FCE (Food Canning Establishment) registration and SID (Scheduled Process ID) filing — additional requirements that many Thai exporters overlook, resulting in U.S. import refusals.
What Thai exporters need:
- FDA Food Facility Registration + U.S. Agent
- FCE + SID registration for canned / LACF products
- CDRH registration for medical device & glove manufacturers
- MoCRA cosmetic facility registration for beauty exporters
- HACCP compliance for seafood facilities
Thai canned food exporters: FCE/SID registration is separate from standard food facility registration and involves a 4–8 week FDA review process. Regovant handles the complete FCE + SID process. Learn about FCE & SID →
FDA Registration for Indonesia Exporters
Indonesia is a significant exporter of food products, seafood, rubber gloves, medical devices, and palm oil-derived ingredients to the United States. Indonesian coffee, cocoa, spices, and processed seafood all require FDA facility registration before entering the U.S. market.
What Indonesian exporters need:
- FDA Food Facility Registration + U.S. Agent
- Prior Notice for every U.S.-bound food shipment
- CDRH device registration for medical device manufacturers
- MoCRA registration for cosmetic facilities
FDA Registration for Philippines Exporters
The Philippines exports processed foods, canned goods, coconut products, seafood, and medical devices to the United States. Coconut-derived products (coconut oil, coconut sugar, coconut water) are particularly significant Philippine exports that require FDA facility registration.
What Philippine exporters need:
- FDA Food Facility Registration + U.S. Agent
- FCE + SID for canned / low-acid products
- CDRH registration for medical device exporters
- MoCRA for cosmetic manufacturers
FDA Registration for Bangladesh Exporters
While Bangladesh is primarily known for garment exports (not FDA-regulated), the country also exports processed foods, seafood, jute products, and a growing range of pharmaceutical and nutraceutical products to the United States. Any Bangladeshi facility in these categories requires FDA registration.
Bangladesh's frozen shrimp and fish export industry is one of the country's most significant non-garment exports to the U.S. — and it requires active FDA compliance, HACCP certification, and a valid U.S. Agent designation.
What Bangladeshi exporters need:
- FDA Food Facility Registration + U.S. Agent (seafood, food, supplements)
- HACCP compliance for seafood processing facilities
- CDER drug registration for pharmaceutical exporters
- Prior Notice for all food shipments to the U.S.
FDA Registration for Mexico Exporters
Mexico is one of the United States' largest trading partners for FDA-regulated products. Mexican food manufacturers, medical device companies, pharmaceutical firms, and cosmetics exporters all require active FDA registration. Mexico is particularly significant for avocados, processed foods, medical devices, and pharmaceutical products entering the U.S. market.
With the USMCA trade agreement in place, trade flows between Mexico and the U.S. are substantial — but USMCA does not exempt Mexican facilities from FDA registration requirements. Every Mexican facility in an FDA-regulated product category must still register and designate a U.S. Agent.
What Mexican exporters need:
- FDA Food Facility Registration + U.S. Agent
- CDRH device registration for medical device manufacturers
- CDER drug establishment registration for pharmaceutical companies
- MoCRA registration for cosmetics manufacturers
- FSMA FSVP compliance for food importers
USMCA note: The U.S.-Mexico-Canada Agreement provides tariff benefits but does not waive FDA registration or U.S. Agent requirements. Mexican facilities must comply with all FDA registration requirements regardless of USMCA status.
FDA Registration for Colombia Exporters
Colombia is a significant exporter of coffee, fresh flowers (not FDA-regulated), processed foods, and medical devices to the United States. Colombian coffee exporters and food processors require FDA facility registration, while the country's growing medical device manufacturing sector requires CDRH establishment registration.
What Colombian exporters need:
- FDA Food Facility Registration + U.S. Agent
- CDRH device registration for medical device companies
- MoCRA registration for cosmetics exporters
- Prior Notice for all food shipments
FDA Registration for Turkey Exporters
Turkey is a growing exporter of food products, medical devices, pharmaceutical ingredients, and cosmetics to the United States. Turkish food exports — including dried fruits, nuts, processed foods, and confectionery — require FDA Food Facility Registration. Turkey's medical device and pharmaceutical sectors are also expanding their U.S. market presence.
What Turkish exporters need:
- FDA Food Facility Registration + U.S. Agent
- CDRH device registration for medical device manufacturers
- CDER registration + NDC for pharmaceutical exporters
- MoCRA for cosmetic facilities
FDA Registration for UK Exporters
Post-Brexit, UK companies exporting FDA-regulated products to the United States face exactly the same requirements as any other foreign facility — including mandatory FDA registration and U.S. Agent designation. EU membership previously meant UK companies operated under EU regulatory frameworks aligned with FDA requirements, but the UK now operates independently.
UK food manufacturers, pharmaceutical companies, medical device firms, and cosmetics brands all need FDA registration and a valid U.S. Agent to legally export to the U.S. market. The UK is a significant exporter of specialty foods, pharmaceuticals, medical devices, and premium cosmetics to the USA.
What UK exporters need:
- FDA Food Facility Registration + U.S. Agent for food/supplement exporters
- CDER drug establishment registration for pharmaceutical companies
- CDRH registration for medical device manufacturers
- MoCRA registration for UK cosmetics brands
- Annual renewal management for devices, drugs, and cosmetics
Post-Brexit note: UK Responsible Persons and UK Authorised Representatives used for MHRA compliance do not fulfil the U.S. FDA U.S. Agent requirement. A separate, U.S.-based U.S. Agent is required for FDA compliance.
FDA Registration for Netherlands & European Exporters
The Netherlands is Europe's largest port and a major hub for FDA-regulated product re-export to the United States. Dutch food companies, pharmaceutical manufacturers, medical device firms, and cosmetics brands — as well as European exporters using Rotterdam or Amsterdam as their export hub — all require FDA registration for U.S.-bound products.
For all EU member states — including Germany, France, Italy, Spain, Belgium, Sweden, Denmark, Poland, and beyond — the same rule applies: EU membership provides no exemption from U.S. FDA registration. Every European facility manufacturing FDA-regulated products for the U.S. market must register and designate a U.S. Agent.
What European exporters need:
- FDA Food Facility Registration + U.S. Agent for food & supplement manufacturers
- CDER drug registration + NDC for EU pharmaceutical exporters
- CDRH establishment registration for medical device companies
- MoCRA registration for European cosmetics brands
- CE marking does NOT fulfil FDA device requirements — separate U.S. registration required
Important for EU medical device manufacturers: CE marking and EU MDR compliance do not fulfil FDA requirements. European medical device companies still need separate FDA establishment registration, device listing, and U.S. Agent designation to legally sell in the United States.