Brazil & the U.S. Market — Why FDA Compliance Matters
Brazil is Latin America's largest economy and the United States' most important South American trading partner, with Brazil-USA trade exceeding $100 billion annually. Brazilian food products, cosmetics, medical devices, and pharmaceutical ingredients are all significant U.S. import categories — all requiring FDA registration and U.S. Agent designation.
Brazil's ANVISA regulatory approval does not substitute for U.S. FDA registration. Brazilian facilities must register separately with the FDA and designate a physical U.S. Agent regardless of their ANVISA compliance status.
Important: ANVISA certification in Brazil does not fulfil U.S. FDA requirements. Brazilian food manufacturers, cosmetics companies, and medical device firms all need separate FDA registration and a U.S. Agent — regardless of their ANVISA compliance status.
Which Brazil Products Require FDA Registration
The following Sri Lankan export categories require FDA registration and a designated U.S. Agent:
Coffee, Food & Agricultural Products
Brazil is the world's largest coffee producer and a major exporter of processed foods, juices, soy-based products, and agricultural goods to the U.S. All Brazilian food processing and export facilities require FDA Food Facility Registration and U.S. Agent designation.
Cosmetics & Beauty Products
Brazil has one of the world's largest cosmetics industries. Brazilian cosmetics manufacturers exporting to the U.S. must comply with MoCRA (2023) — mandatory FDA facility registration, product listing, and U.S.-based Responsible Person designation. Brazilian beauty brands targeting U.S. retail must be MoCRA-compliant.
Medical Devices & Equipment
Brazilian medical device manufacturers require annual CDRH establishment registration, device listing, and U.S. Agent designation. Brazil's growing medical technology sector is increasingly targeting U.S. market entry, requiring full FDA compliance independent of ANVISA approval.
Pharmaceuticals & APIs
Brazilian pharmaceutical manufacturers and API suppliers exporting to the U.S. require CDER drug establishment registration, NDC Labeler Code, and U.S. Agent designation. ANVISA approval does not substitute for FDA registration.
The U.S. Agent Requirement for Sri Lankan Exporters
Every Brazil facility registering with the FDA must designate a U.S. Agent — a person or company physically located in the United States. This is a legal requirement under 21 CFR; without a valid U.S. Agent your FDA registration will be rejected.
The U.S. Agent acts as the FDA's domestic point of contact for your Sri Lankan facility. They receive all official FDA communications on your behalf, assist with inspection coordination, and ensure critical notices reach you in time. Choosing the wrong U.S. Agent is one of the most common and costly mistakes Sri Lankan exporters make.
Regovant LLC is a trusted FDA U.S. Agent for Brazil exporters, physically based in Casper, Wyoming USA. Learn about our U.S. Agent services →
How to Get FDA Registered as a Sri Lankan Exporter
Identify Your Product Category
Confirm whether your products fall under food, dietary supplement, medical device, drug, or cosmetics — each has different registration requirements and renewal timelines.
Designate a U.S. Agent
Select a physically U.S.-incorporated regulatory firm as your U.S. Agent. This is required before registration can proceed. Ensure they cover your specific product category.
Register in FDA's FURLS System
Your U.S. Agent submits your facility registration through the FDA Unified Registration and Listing System (FURLS). For food facilities, this includes your D-U-N-S number, facility details, and product categories.
Receive Your FEI Number & Certificate
Upon successful registration, the FDA issues your FDA Establishment Identifier (FEI) number. Your U.S. Agent delivers your official Certificate of Registration — the document your U.S. importers will request.
Maintain Compliance & Renew
Food facilities renew every 2 years (odd-numbered years: 2025, 2027). Medical devices, drugs, and cosmetics renew annually. Your U.S. Agent handles renewal reminders and submissions.
FDA Registration Costs for Sri Lankan Companies
The FDA itself charges no government fee for food facility registration, medical device establishment registration, or MoCRA cosmetics registration. The cost you pay goes entirely to your service provider for handling the registration on your behalf.
Regovant's fixed pricing for Sri Lankan exporters:
- Food Facility Registration + U.S. Agent + Certificate: $300/year
- Medical Device Establishment + U.S. Agent + Certificate: $550/year
- Drug Establishment + NDC + U.S. Agent + Certificate: $550/year
- Cosmetic Facility Registration (MoCRA) + Certificate: $650/year
- Additional food facility (same owner): $150/year
Note for Brazil exporters: Many Brazil facilities export multiple FDA-regulated product types. Each distinct product category may require separate registration. Regovant can assess your full product range and advise which registrations are actually required.
Why Brazil Exporters Choose Regovant
Regovant LLC serves Brazil exporters across multiple FDA product categories. We understand the specific challenges Brazil manufacturers face when navigating U.S. FDA compliance requirements and market entry.
FDA Registration for Brazilian Manufacturers — From $300/Year
Regovant handles FDA registration for Brazilian food exporters, cosmetics brands, medical device manufacturers, and pharmaceutical companies. Physical U.S. presence in Wyoming. ANVISA does not substitute for FDA registration — Regovant handles the complete U.S. process.