U.S. FDA Registration Services in Australia
FDA Registration Assistance provides U.S. FDA registration and regulatory consulting for Australian companies that export food, wine, seafood, honey, dietary supplements and complementary medicines, sunscreens and skincare, pharmaceuticals, and medical devices to the United States. As a U.S.-based firm, we help Australian manufacturers, brand owners, and exporters register foreign facilities, appoint a U.S. Agent where required, coordinate FSVP and Prior Notice with U.S. importers, review labeling and claims, and complete drug, device, and cosmetic requirements before products reach the U.S. market.
Confirm which FDA programs apply before your first U.S. shipment. Tell us what your Australian company produces or exports, where each product is made or packed, and who will import it. We can identify the registrations, U.S. Agent, label and claim, Prior Notice, and importer questions to address, handled remotely from the United States.
Request My Australia FDA AssessmentFDA Registration for Australia Exporters Entering the U.S. Market
A National Service Area
Australia's exporters span Sydney and Melbourne, the Queensland agriculture of Brisbane, the Western Australian ports around Fremantle, the wine regions of South Australia, and the country's seafood, honey, supplement, and skincare sectors. Wherever an Australian company is based, FDA requirements apply the same way when its products are sold into the United States, and we support businesses nationwide from our U.S. office.
FDA-Regulated Products
FDA requirements may apply to foods, including wine, seafood, honey, and nuts, as well as dietary supplements, cosmetics, sunscreens and other OTC drugs, prescription drugs, and medical devices, depending on intended use, labeling, ingredients, claims, manufacturing, and how products are exported and imported into the United States.
Foreign-Facility Support
FDA Registration Assistance is based in Miami, Florida and supports Australian exporters remotely with foreign facility registration, U.S. Agent service where FDA requires one, FSVP coordination, labeling, drug and device listing, and import compliance, with particular depth in supplement, sunscreen and skincare, wine, and seafood exports.
Australia's FDA Equivalent: TGA and FSANZ vs the U.S. FDA
One of the most common points of confusion for Australian exporters is the relationship between the country's own regulator and the U.S. Food and Drug Administration. Australia has no single "Australian FDA." The Therapeutic Goods Administration (TGA) regulates therapeutic goods, including prescription and OTC medicines, complementary medicines such as vitamins and herbal products, most sunscreens, and medical devices. Food Standards Australia New Zealand (FSANZ) sets the food standards, while the Department of Agriculture, Fisheries and Forestry oversees imported food and export certification. These bodies operate under Australian law, and the U.S. FDA governs products entering the United States.
These are two different systems, and clearing one does not clear the other. An ARTG entry, an AUST L or AUST R number, or a TGA device inclusion is not recognized by the U.S. FDA, so a medicine, device, food, supplement, or cosmetic that is fully compliant in Australia still needs its own U.S. FDA registration, listing, labeling, and, where relevant, U.S. Agent representation before it can be exported to the United States. In the same way, completing FDA requirements does not replace any Australian obligation. You can review the FDA's own overview of importing FDA-regulated products for context. Our role is to handle the U.S. FDA side so that a company already meeting its home requirements can add U.S. market access cleanly.
How FDA Requirements Apply Across Australia's Export Sectors
Australia exports across several FDA-regulated categories, and each follows a different pathway. This overview shows how the main requirements map to the sectors Australian companies most often ship to the United States.
| Export Sector | Primary FDA Pathway | Key Point for Australia Exporters |
|---|---|---|
| Food & Agricultural Products | Foreign food facility registration, U.S. Agent, Prior Notice, FSVP | Facilities that make, pack, or hold food generally register; the U.S. importer generally needs an FSVP, and each shipment needs Prior Notice. |
| Wine, Seafood & Beef | Food facility registration and Prior Notice, seafood HACCP, TTB for wine, USDA FSIS for meat, importer FSVP | Wineries register with FDA and need TTB label approval; seafood processors follow FDA seafood HACCP; Australian beef, lamb, and goat go through USDA, not FDA. |
| Dietary Supplements | Food facility registration, Part 111 CGMP readiness, label and claim review | An AUST L complementary medicine is a dietary supplement in the U.S. There is no FDA product registration; the facility registers, follows 21 CFR Part 111, and Supplement Facts and claims must meet U.S. rules. |
| Cosmetics & Personal Care | MoCRA facility registration, product listing, Responsible Person | MoCRA added facility registration, product listing, adverse event reporting, and safety substantiation; the Responsible Person is the firm named on the label. SPF products are not cosmetics in the U.S. |
| Sunscreens & SPF Skincare | OTC drug establishment registration, listing, NDC, U.S. Agent, Drug Facts | Sunscreens are OTC monograph drugs in the U.S. Active ingredients must be in the FDA sunscreen monograph, and facilities owe an annual OMUFA fee. |
| Pharmaceuticals | Drug establishment registration, listing, NDC, U.S. Agent | Foreign drug establishments register and list before their drugs are imported, separate from TGA registration. |
| Medical Devices | Establishment registration, device listing, classification review, U.S. Agent | Requirements depend on FDA classification; many Class II devices need 510(k) clearance, and ARTG inclusion does not substitute for it. |
FDA Planning Points for Australian Exporters
The United States imported about $29.0 billion in goods from Australia in 2025 (U.S. Census Bureau). Only part of that is FDA-regulated, and Australian products cross more agencies than most: beef, lamb, and goat go through USDA, which lists Australia as eligible to export them (USDA FSIS), wine adds TTB, and everything else is screened by FDA at entry. Three questions come up most often:
AUST L Supplements Become U.S. Dietary Supplements
In Australia, vitamins, minerals, and herbal products are listed complementary medicines with an AUST L number (TGA). In the U.S. they are dietary supplements: no product approval, but the facility registers as a food facility, follows the 21 CFR Part 111 CGMP rule, and uses a U.S. Agent. TGA indications often need rewording, because a structure/function claim needs the FDA disclaimer and a notification within 30 days of first marketing (FDA), and disease claims are not allowed.
Sunscreens Are OTC Drugs in the U.S.
Most Australian sunscreens are listed with the TGA (TGA); in the U.S. they are OTC monograph drugs, so the maker registers as a drug establishment, lists each product with an NDC, uses Drug Facts labeling, and pays the OMUFA facility fee, $47,891 for FY 2027 (FDA). Only monograph active ingredients may be used. Bemotrizinol was added in June 2026 (FDA), but other UV filters common in Australian formulas still need an approved application.
Recognition, the FTA, and MDSAP Do Not Waive Registration
FDA signed a food safety systems recognition arrangement with Australia in April 2017 (Australian Department of Agriculture); it lets importers use modified FSVP requirements for certain foods but excludes dietary supplements, Grade A dairy, alcohol, and bivalve shellfish (FDA). The U.S.-Australia FTA, in force since January 1, 2005 (ITA), affects tariffs, not FDA rules. MDSAP audits are shared by TGA and FDA (MDSAP), but device makers still register, list, and obtain clearance.
The 2026 biennial food facility renewal window runs from October 1 to December 31, 2026; existing Australian food and supplement facility registrations must be renewed in that period to stay valid (renewal help). For city-level detail, see the Australia city guides below.
FDA Consulting by City in Australia
We publish dedicated FDA service area pages for Australia's commercial and manufacturing centers. Explore the city guides below for local detail, or contact us directly if your city is not yet listed — we support exporters across the whole country.
FDA Consulting in Sydney, Australia
Australia's largest city and a major port — supplement, skincare and sunscreen, food, pharmaceutical, and medical device exporters and brand owners.
FDA Consulting in Melbourne, Australia
A leading commercial and food-processing center and port — dairy, meat, food, and consumer-product exporters.
FDA Consulting in Brisbane, Australia
A Queensland port and gateway for northern agriculture — beef, macadamia, tropical food, and seafood exporters.
FDA Consulting in Fremantle, Australia
Western Australia's main port near Perth — seafood, rock lobster, grain, and food exporters.
How FDA Registration Works for an Australian Company
1. Product and Facility Review
We review your products, facilities, and target U.S. market to determine which FDA categories and registrations apply across food, supplement, cosmetic, drug, and device lines.
2. Pathway and U.S. Agent Setup
We identify the required registrations and listings, obtain a DUNS number where needed, and put U.S. Agent representation in place where FDA requires a U.S. contact.
3. Filing and Labeling
We prepare and submit the registrations and listings, review labels and claims against U.S. rules, and coordinate FSVP and Prior Notice with your U.S. importer.
4. Ongoing Compliance
We manage renewals, keep registrations and listings current, and support FDA communications, so your Australian company stays compliant as it grows in the U.S. market.
Need U.S. FDA Registration Services in Australia?
Whether you export supplements, sunscreens and skincare, wine, seafood, other foods, pharmaceuticals, or medical devices, FDA Registration Assistance can map your pathway and handle the U.S. FDA side from start to finish.
- Identify which FDA programs apply to each product and each manufacturing or packing site in Australia.
- Confirm U.S. Agent, Prior Notice, FSVP, labeling, and claim responsibilities with your U.S. importer.
- Agree the scope, required documents, and pricing before any paid work begins.
Contact our specialists to get started. View registration pricing, learn about FDA Registration Assistance, or see all service areas.
Request My Australia FDA AssessmentFDA Registration Assistance is a private consulting firm, not FDA. Professional assistance is not government approval or a guarantee of a regulatory outcome.
Frequently Asked Questions About FDA Registration in Australia
1. Do companies in Australia need FDA registration to sell products in the United States?
Most do. Any Australian business that manufactures, processes, packs, holds, labels, or exports FDA-regulated food, dietary supplements, cosmetics, drugs, or medical devices to the United States is treated as a foreign facility or foreign establishment and must meet the applicable FDA registration, listing, and U.S. Agent requirements before products enter the U.S. market.
2. Is U.S. FDA registration the same as registering with the TGA, the Therapeutic Goods Administration?
No. The Therapeutic Goods Administration (TGA) is Australia's regulator for medicines, complementary medicines, most sunscreens, and medical devices, and Food Standards Australia New Zealand (FSANZ) sets food standards; their approvals and listings govern the Australian market. U.S. FDA registration is a separate, U.S. requirement that applies when products are exported to the United States. A product listed or registered on the ARTG still needs its own FDA compliance to enter the U.S., and clearing FDA does not replace any Australian requirement.
3. Does the U.S. FDA have an office in Australia?
No. FDA has no office in Australia that registers or approves companies (FDA foreign offices). Foreign facilities interact with the U.S. FDA through its online registration systems, and food facilities and drug and device establishments do so through a U.S. Agent based in the United States.
4. Which FDA-regulated products does Australia most commonly export?
Australian exporters commonly deal with wine, seafood, honey, macadamias, dairy, packaged and processed foods, complementary medicines sold in the U.S. as dietary supplements, sunscreens and skincare, cosmetics and personal care products, and pharmaceuticals and medical devices; beef and lamb go through USDA instead of FDA. Each category has its own FDA pathway, and the right one depends on the product, its intended use, and its labeling.
5. Do Australian exporters need a U.S. Agent?
Yes, in every FDA program that registers foreign facilities. Foreign food and dietary supplement facilities and foreign drug, sunscreen, and medical device establishments must designate a U.S. Agent located in the United States, who serves as FDA's contact for communications, inspection scheduling, and emergencies. Foreign cosmetic facilities registering under MoCRA must name one too. FDA Registration Assistance can serve as the U.S. Agent for eligible Australian food, supplement, drug, device and cosmetic establishments.
6. Does FDA registration mean the FDA has approved an Australian product?
No. For most foods, supplements, and cosmetics, registration and listing are compliance steps, not an approval or endorsement. The FDA does not pre-approve these products, and it is misleading to describe registration as FDA approval. Drugs and certain devices involve additional review pathways that are separate from basic establishment registration.
7. Can one FDA registration cover a company's whole operation in Australia?
Not always. Registration is generally facility and product-category specific, so a company that operates more than one facility, or that ships across food, drug, device, or cosmetic categories, may need several registrations and listings. We map which registrations apply across an Australian company's sites and product lines.
8. How long does FDA registration take for an Australian company?
Many foreign food and supplement facility registrations can be completed within a few business days once the facility details, product information, DUNS number, and U.S. Agent are in place. Drug, device, and cosmetic pathways can take longer because of listing, classification, and labeling steps, so timelines depend on the product category.
9. Which Australian cities does FDA Registration Assistance support?
We support businesses across Australia, working remotely from our U.S. base. We have dedicated service area pages for Sydney, Melbourne, Brisbane, and Fremantle, covering the main east- and west-coast commercial centers and ports, and we assist exporters in Adelaide, Perth, Hobart, and other regions as well.
10. What FDA rules apply to Australian wine, beef, seafood, and supplement exporters?
Different products go to different U.S. agencies. Wine and other alcoholic beverages involve both the FDA and the U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB), which handles alcohol permits and label approval. Beef, lamb, mutton, veal, and goat fall under USDA's Food Safety and Inspection Service rather than FDA, and Australia is an eligible exporting country for them (USDA FSIS). Seafood such as rock lobster follows the FDA's seafood HACCP rules, and supplements, honey, macadamias, dairy, and packaged foods are FDA-regulated, requiring food facility registration, Prior Notice, and compliant labeling, with the U.S. importer handling FSVP. Because Australia exports across so many categories, getting each product to the correct agency and registration is what keeps shipments moving through U.S. entry, and we map which apply to a specific Australian exporter's products.
11. Do Australian food and supplement exporters need FSVP?
The Foreign Supplier Verification Program is generally the U.S. importer's responsibility, but it directly affects Australian suppliers because the importer must verify that the foreign supplier meets U.S. food safety standards. Because FDA recognizes Australia's food safety system as comparable, importers can use modified FSVP requirements for certain foods not intended for further processing from suppliers in good compliance standing; dietary supplements, Grade A dairy, and alcohol are excluded from that arrangement (FDA systems recognition). We coordinate FSVP between Australian exporters and their U.S. importers so the verification records are in place.
12. How do I start FDA registration for an Australian company?
The simplest first step is a short review of your products, facilities, and target U.S. market. From there we identify which FDA registrations, listings, U.S. Agent service, and labeling steps apply, and we handle the filings. You can contact FDA Registration Assistance by email, phone, or the form at the bottom of this page to begin.
13. Do the U.S.-Australia free trade agreement or FDA's food safety recognition of Australia remove FDA requirements?
No. The U.S.-Australia Free Trade Agreement has been in force since January 1, 2005 (ITA), and FDA signed a food safety systems recognition arrangement with Australia in 2017 (FDA), but FDA has no drug or device mutual recognition agreement with Australia (FDA), and no arrangement lets an Australian company skip U.S. FDA registration or Prior Notice. The FTA can affect tariffs and customs treatment, and systems recognition can simplify the importer's FSVP for some foods, but they do not change FDA's product safety, registration, listing, or labeling requirements, which apply based on the product and its use in the United States.
14. Are FDA fees different for companies in Australia?
FDA's fee structure is based on the product category and activity, not the exporter's country. Medical device establishments pay an annual FDA registration user fee, and OTC monograph drug facilities, including sunscreen makers, pay an annual OMUFA facility fee of $47,891 for FY 2027 (FDA), while food, supplement, and cosmetic facility registration have no FDA registration fee. We outline any applicable government fees and our service fees up front for each Australian pathway.
15. Can an Australian company register with the FDA on its own?
A company can attempt registration itself, but foreign facilities must appoint a U.S. Agent, obtain a DUNS number, and navigate category-specific listing and labeling rules, which is where errors commonly cause border problems. Using an experienced firm reduces the risk of rejected filings, misclassification, and shipments held at entry.
16. What is a DUNS number and do Australian facilities need one?
A DUNS number is a unique business identifier that FDA uses to verify a facility's identity for food facility registration and drug establishment registration. Foreign facilities in Australia generally need a valid DUNS number that matches the facility's legal name and address before registration can be completed, and we help obtain or correct it where needed.
17. How often must an Australian company renew its FDA registration?
It depends on the category. Food and supplement facility registrations renew every two years between October 1 and December 31 of each even-numbered year, so the current window runs to December 31, 2026. Cosmetic facility registrations renew every two years and MoCRA product listings are updated annually, while drug and device establishment registrations renew annually, with an annual user fee for devices. We track renewal windows so an Australian company's registrations do not lapse.
18. Does FDA inspect facilities located in Australia?
The FDA can inspect foreign facilities, and it also relies on import screening, records, and importer verification. Device makers audited under MDSAP, in which both TGA and FDA participate, can use that audit report in place of a routine FDA inspection (MDSAP). Whether or not an inspection happens, an Australian facility is expected to meet the applicable U.S. standards, keep records, and respond to FDA, through its U.S. Agent where one is required, so readiness matters regardless of inspection frequency.
19. What happens to an Australian shipment that arrives without proper FDA registration?
The FDA can detain or refuse the shipment at the U.S. port, which usually means storage costs, delays, and possible return or destruction of the goods. Getting registration, labeling, product coding, Prior Notice, and importer verification right before the goods ship is the way to avoid these outcomes.
20. Can FDA Registration Assistance help Australian exporters with U.S. labeling?
Yes. We review labels against U.S. requirements, including required statements, Nutrition Facts or Supplement Facts formatting, ingredient and allergen declarations, claims, net quantity, and the responsible firm's U.S. contact details, so products are labeled correctly before printing and export.
21. Do Australian cosmetics need FDA registration under MoCRA?
Generally yes. Under MoCRA, facilities that manufacture or process cosmetics for the U.S. market register with FDA, and the Responsible Person, the manufacturer, packer, or distributor named on the label, lists each product. Small businesses may be exempt from some requirements, and any product with an SPF claim is an OTC drug rather than a cosmetic. Australian cosmetic and personal care brands should confirm facility registration, product listing, labeling, and safety substantiation before entering the U.S. market.
22. Are dietary supplements from Australia treated as food or as drugs by the FDA?
The FDA regulates dietary supplements as a category of food, not as drugs, so a product sold in Australia as an AUST L complementary medicine is generally a dietary supplement in the U.S., with no FDA product registration. The Australian facility generally needs food facility registration and must follow supplement labeling rules and the dietary supplement CGMP rule in 21 CFR Part 111; a product with a new dietary ingredient may need a premarket notification. Claims are important: TGA-permitted indications often need rewording, structure/function claims need the FDA disclaimer and a notification to FDA within 30 days of first marketing, and a supplement that makes disease claims can be treated as an unapproved drug.
23. Can FDA Registration Assistance act as the U.S. Agent for an Australian exporter long term?
Yes. We provide ongoing U.S. Agent representation for eligible Australian food and supplement facilities and drug and device establishments, serving as FDA's required U.S. contact for communications, inspection scheduling, and emergencies for as long as the registration is active.
24. Does FDA registration expire if an Australian company stops exporting for a while?
Registrations must be kept current and renewed on schedule, and a lapse can require re-registration before shipping resumes. If an Australian company pauses exports, it is usually better to keep the registration active and renewed than to let it expire and rebuild it later, and we can advise on the best approach.
25. Why should an Australian company choose FDA Registration Assistance?
We are a U.S.-based firm focused on foreign facility and foreign exporter FDA compliance, so we understand both the FDA's requirements and the practical realities Australian exporters face. We map the pathway across food, supplement, cosmetic, drug, and device categories, handle the filings, serve as U.S. Agent where one is required, and support renewals and FDA communications end to end.
Request FDA Support for Your Australian Business
Tell us what your company makes, sells, or distributes, where each product is manufactured or packed, your U.S. importer or buyer arrangement, label readiness, and target shipment date.
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