Australia & the U.S. Market — Why FDA Compliance Matters
Australia is one of the United States' closest allies and a significant trading partner, with the U.S. running a trade surplus with Australia of over $17 billion annually. Australian food products, pharmaceuticals, medical devices, and cosmetics are all significant U.S. import categories — all requiring FDA registration and U.S. Agent designation.
A critical point for Australian manufacturers: TGA (Therapeutic Goods Administration) approval does not fulfil U.S. FDA requirements. Australian medical device companies, pharmaceutical firms, and food manufacturers must register separately with the FDA and designate a U.S. Agent to legally sell in the United States.
Important: TGA approval and ARTG listing in Australia do not fulfil U.S. FDA requirements. Australian medical device companies and pharmaceutical firms must register separately with the FDA and designate a U.S. Agent — regardless of TGA compliance status or ARTG listing.
Which Australia Products Require FDA Registration
The following Sri Lankan export categories require FDA registration and a designated U.S. Agent:
Food, Meat & Agricultural Products
Australian food manufacturers, beef and lamb processors, dairy exporters, and packaged food companies exporting to the U.S. require FDA Food Facility Registration and U.S. Agent designation. Australia is a significant exporter of premium food products to the U.S. market.
Pharmaceuticals & Biologics
Australian pharmaceutical manufacturers and biologics companies exporting to the U.S. require CDER drug establishment registration, NDC Labeler Code, and U.S. Agent designation. TGA approval and ARTG listing do not substitute for FDA registration.
Medical Devices & Equipment
Australian medical device manufacturers require annual CDRH establishment registration, device listing, and U.S. Agent designation. TGA approval and ARTG listing are separate from FDA requirements — Australian device companies need both for their respective markets.
Cosmetics, Supplements & Natural Products
Australian cosmetics manufacturers, natural skincare brands, and dietary supplement companies exporting to the U.S. must comply with MoCRA for cosmetics and DSHEA for supplements. Australian natural health products are popular in the U.S. market.
The U.S. Agent Requirement for Sri Lankan Exporters
Every Australia 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 Australia 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 Australia exporters: Many Australia 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 Australia Exporters Choose Regovant
Regovant LLC serves Australia exporters across multiple FDA product categories. We understand the specific compliance challenges Australia manufacturers face when entering the U.S. market.
FDA Registration for Australian Manufacturers — From $300/Year
Regovant handles FDA registration for Australian food exporters, pharmaceutical companies, medical device manufacturers, and cosmetics brands. TGA approval does not replace FDA registration — Regovant handles the complete U.S.-specific compliance process.