Vietnam & the U.S. Market — Why FDA Compliance Matters
Vietnam is one of the United States' most significant trading partners for FDA-regulated products. The U.S. trade deficit with Vietnam exceeds $110 billion annually, driven by seafood, coffee, processed foods, footwear, and a rapidly growing electronics and medical device manufacturing sector.
Vietnam is the #1 source of U.S. shrimp imports and a top exporter of catfish, pangasius, and other aquaculture products. Every Vietnamese facility behind these exports must register with the FDA and designate a U.S. Agent — and Vietnam's seafood industry is among the most actively screened at U.S. ports of entry.
Important: Vietnam is one of the most frequently FDA-screened countries at U.S. ports. Vietnamese seafood exporters in particular face regular HACCP audits and import alerts. Active U.S. Agent representation and compliance management are essential — not optional.
Which Vietnam Products Require FDA Registration
The following Sri Lankan export categories require FDA registration and a designated U.S. Agent:
Seafood, Shrimp & Aquaculture
Vietnam is the world's leading shrimp exporter to the U.S. All Vietnamese seafood processing facilities must register with the FDA, comply with HACCP seafood regulations, and submit Prior Notice for every U.S.-bound shipment. Active FDA import alerts for Vietnamese seafood make reliable U.S. Agent coverage critical.
Coffee, Tea & Processed Foods
Vietnam is the world's second-largest coffee producer. Vietnamese coffee exporters, food manufacturers, and processed food companies require FDA Food Facility Registration and U.S. Agent designation before exporting to the U.S. market.
Medical Devices & Equipment
Vietnam's medical device manufacturing sector is growing rapidly — particularly gloves, surgical instruments, and diagnostic equipment. Vietnamese device manufacturers require annual CDRH establishment registration, device listing, and U.S. Agent designation under 21 CFR Part 807.
Cosmetics & Personal Care
Vietnamese 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. Vietnam's growing beauty manufacturing sector is increasingly targeting the U.S. market.
The U.S. Agent Requirement for Sri Lankan Exporters
Every Vietnam 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 Vietnam 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 Vietnam exporters: Many Vietnam 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 Vietnam Exporters Choose Regovant
Regovant LLC serves Vietnam exporters across multiple FDA product categories. We understand the specific compliance challenges Vietnam manufacturers face when entering the U.S. market.
FDA Registration for Vietnamese Manufacturers — From $300/Year
Regovant handles FDA registration for Vietnamese seafood facilities, food exporters, medical device manufacturers, and cosmetics brands. Physical U.S. presence in Wyoming. HACCP compliance guidance included. Certificate of Registration with every service.