Canada & the U.S. Market — Why FDA Compliance Matters
Canada is one of the United States' largest and most integrated trading partners, with bilateral trade exceeding $900 billion annually. Canadian food manufacturers, pharmaceutical companies, medical device firms, and natural health product exporters all have significant U.S. market presence.
Despite close regulatory alignment between Health Canada and the FDA, and USMCA providing significant trade benefits, Canadian manufacturers must independently register with the FDA and designate a U.S. Agent. Health Canada approval and Medical Device Licences do not substitute for U.S. FDA registration.
Important: USMCA and Health Canada approval do not waive FDA registration requirements. Canadian food manufacturers, natural health product companies, medical device firms, and pharmaceutical exporters must all independently register with the FDA and designate a U.S. Agent.
Which Canada Products Require FDA Registration
The following Sri Lankan export categories require FDA registration and a designated U.S. Agent:
Food, Dairy & Processed Foods
Canada is a major U.S. food import source — dairy, grain, seafood, and packaged goods. All Canadian food manufacturing facilities require FDA Food Facility Registration and U.S. Agent designation. USMCA does not waive this requirement.
Pharmaceuticals & Natural Health Products
Canadian pharmaceutical manufacturers and natural health product companies require CDER drug establishment registration, NDC Labeler Code, and U.S. Agent designation. Health Canada's Drug Identification Number (DIN) does not substitute for FDA registration.
Medical Devices & Equipment
Canadian medical device manufacturers require annual CDRH establishment registration, device listing, and U.S. Agent designation. Health Canada's Medical Device Licence (MDL) does not fulfil FDA requirements — separate U.S. registration is required.
Cosmetics & Natural Beauty
Canadian 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. Canada's natural and clean beauty sector is a significant U.S. export category.
The U.S. Agent Requirement for Sri Lankan Exporters
Every Canada 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 Canada 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 Canada exporters: Many Canada 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 Canada Exporters Choose Regovant
Regovant LLC serves Canada exporters across multiple FDA product categories. We understand the compliance challenges Canada manufacturers face when entering the U.S. market.
FDA Registration for Canadian Manufacturers — From $300/Year
Regovant handles FDA registration for Canadian food exporters, pharmaceutical companies, medical device manufacturers, and cosmetics brands. Health Canada and USMCA do not replace FDA registration — Regovant handles the complete U.S.-specific compliance process.