FDA Registration for South African Exporters
We handle all FDA filings for South African food, cosmetics, and product companies.
What do South African businesses need to do to enter the US market?
South Africa is one of Africa's leading exporters, producing world-class wine, citrus fruit, rooibos tea, processed foods, and cosmetics. Companies from Johannesburg, Cape Town, Durban, and Pretoria are increasingly looking to expand into the United States market.
To export food to the United States, South African production facilities must register with the FDA before their first shipment. This involves FDA Food Facility Registration, appointing a US Agent, and obtaining a DUNS number when required. For cosmetics, the MoCRA law effective since 2023 requires foreign brands to register their facilities and product listings with the FDA.
We help businesses from Johannesburg, Cape Town, Durban, and throughout South Africa complete the entire process online — no need to travel to any office.
Services for South African exporters
Questions from South African exporters
Do South African food manufacturers need to register with the FDA?+
Yes. Any facility that manufactures, processes, packs, or holds food for export to the United States must register with the FDA before the first shipment.
How long does FDA registration take?+
Food and cosmetics registrations typically complete within 3–5 business days after all required documents are received.
What is a US Agent?+
A US Agent is a person or company based in the United States listed in the foreign facility's FDA registration. The FDA sends all official notices and inspections through this person.
How much does FDA registration cost?+
Our Food and Cosmetics packages start at USD 449, including DUNS number, FDA facility registration, and US Agent service for the first year.
Articles for South African exporters
FDA Registration Guide for Food Manufacturers in Johannesburg, Cape Town, and Durban
Food producers from Johannesburg, Cape Town, and Durban are expanding their exports to the United States. This guide explains the FDA Food Facility Registration process and the documents you need before your first shipment.
Exporting South African Cosmetics to the USA: MoCRA Requirements and FDA Registration
The MoCRA law requires all foreign cosmetics brands to register facilities and products with the FDA before selling in the US market. Here is what manufacturers in Cape Town and Johannesburg need to know.
What Is a DUNS Number and Why Food Exporters Need One Before FDA Registration
The DUNS number is a 9-digit identifier required by FDA before food facility registration. A complete guide for South African exporters.
How a Foreign Company Can Export Food to the United States: FDA Requirements for South African Exporters
Complete guide for South African food manufacturers seeking entry to the US market: FDA facility registration, DUNS number, US Agent and Prior Notice.
What Is OMUFA and What It Means for South African OTC Drug Manufacturers
OMUFA imposes mandatory annual fees on foreign OTC drug manufacturers. Guide for South African companies selling OTC products in the United States.
FDA Drug Establishment Registration: What South African Manufacturers Must File
For South African companies exporting drugs to the US: FDA drug facility registration via DRLS, annual renewal and US Agent requirement.
What Is an NDC Number and How South African Drug Manufacturers Obtain One
The National Drug Code (NDC) is a mandatory identifier for every drug product sold in the US. Guide to Labeler Code and NDC for South African manufacturers.
FDA Drug Labeling Requirements: What South African Manufacturers Must Include
FDA regulations determine drug labeling requirements in the US. Key labeling requirements for South African manufacturers exporting to the United States.
Medical Device Labeling Symbols: What South African Manufacturers Must Know
US medical device labeling uses standard symbols. Guide to FDA symbol standards for South African medical device manufacturers.
FDA Registration Numbers Explained for South African Exporters: FEI and DUNS
For South African food and drug exporters: explanation of FEI and DUNS numbers encountered in the FDA registration process.
FDA Inspections of Registered South African Facilities
FDA has authority to inspect foreign food and drug facilities. What South African manufacturers need to know about FDA inspections.
US Cosmetic Labeling in 2026: MoCRA Requirements for South African Brands
MoCRA introduced new mandatory labeling elements for South African brands exporting cosmetics to the US. Guide to 2026 requirements.
FDA Food Facility Registration Step by Step: South African Exporters
All steps of FDA facility registration for South African food exporters: from obtaining DUNS to completing registration in FFRPS.
Why FDA Rejects Food Facility Registrations: South African Applicants
Common reasons for FDA food facility registration rejection and how South African companies can avoid them.
What Is a UFI Number and How It Affects South African FDA Registration
The EU UFI number requirement and what it means for South African manufacturers exporting to both the US and Europe.
Documents to Prepare Before FDA Food Registration: South African Manufacturers
List of essential documents South African food manufacturers should gather before starting FDA facility registration.
FDA Export Certificates: When South African Manufacturers Need Them
What FDA export certificates are, when South African manufacturers should request them, and how to obtain them from FDA.
Medical Device Registration for South African Manufacturers
Complete guide to FDA 510(k), PMA and De Novo pathways for South African medical device manufacturers exporting to the US.
FSMA Preventive Controls: What South African Food Manufacturers Need
How FDA's preventive controls rule under FSMA affects South African food exporters and the mandatory Food Safety Plan requirement.
REACH Compliance for South African Exporters to Europe
REACH are EU chemical regulations affecting South African manufacturers that export chemicals or cosmetics to the EU.
DUNS Number FAQ for South African Food Exporters
The most common questions South African food exporters have about the DUNS number and clear answers.
What Is an FEI Number and Why It Matters to South African Exporters
FDA Establishment Identifier (FEI) is the permanent code assigned after registration. Guide to using and tracking FEI for South African exporters.
Ready to export to the United States?
Start your FDA registration today. We guide you through every step.