UAE & the U.S. Market — Why FDA Compliance Matters
The United Arab Emirates — and Dubai in particular — serves as a global trade hub with an increasingly significant manufacturing and re-export role for FDA-regulated products. UAE-based food processors, cosmetic manufacturers, supplement brands, and medical device distributors all have direct pathways to the U.S. market that require active FDA compliance.
For any UAE facility that manufactures, processes, packs, or re-exports FDA-regulated products destined for the United States, FDA registration and a valid U.S. Agent designation are mandatory. This includes facilities in Dubai, Abu Dhabi, Sharjah, and UAE free zones including JAFZA and Dubai Silicon Oasis.
Important: UAE free zone facilities are not exempt from FDA registration. Even if your facility is located in JAFZA, KIZAD, or another UAE free zone, you must still register with the FDA and designate a U.S. Agent before exporting FDA-regulated products to the United States.
Which UAE Products Require FDA Registration
The following Sri Lankan export categories require FDA registration and a designated U.S. Agent:
Food, Dates & Processed Foods
UAE food manufacturers and processors — including date producers, snack manufacturers, and packaged food companies — require FDA Food Facility Registration and U.S. Agent under the Bioterrorism Act before exporting to the U.S.
Cosmetics & Beauty Products
The UAE is a major cosmetics manufacturing and re-export hub. Under MoCRA (2023), UAE cosmetics facilities exporting to the U.S. must register with the FDA, list all products, and designate a U.S.-based Responsible Person. Registration deadlines have passed.
Dietary Supplements & Nutraceuticals
UAE supplement brands and private-label manufacturers exporting to the U.S. require FDA food facility registration, DSHEA-compliant labeling, and a valid U.S. Agent. Claims on supplement labels must meet strict 21 CFR requirements.
Medical Devices & Equipment
UAE medical device manufacturers and distributors exporting to the U.S. require CDRH establishment registration, device listing, and U.S. Agent designation. Device class determines whether 510(k) premarket notification is also required.
The U.S. Agent Requirement for Sri Lankan Exporters
Every UAE 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 UAE 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 UAE exporters: Many UAE facilities export multiple product types across different FDA product categories. Each distinct product category may require separate registration. Regovant can assess your full product range and advise which registrations are actually required.
Why UAE Exporters Choose Regovant
Regovant LLC has active UAE clients across multiple FDA product categories. We understand the specific export challenges UAE manufacturers face when navigating U.S. FDA compliance requirements.
FDA Registration for UAE Manufacturers — From $300/Year
Regovant handles FDA registration for UAE food, cosmetics, device, and supplement exporters. Physical U.S. presence in Wyoming. Certificate of Registration included. Serving clients across the UAE and wider Middle East.