Certificate of Free Sale (CFS) for exports: who issues it, FDA and UK
A Certificate of Free Sale (CFS) confirms that a product complies with the rules of the exporting country and can be sold freely there. Importing countries ask for it, mostly for food, cosmetics, supplements, medicines and medical devices, when they register or clear the product. It is issued by an authority in the exporter's country, so the buyer cannot get it for you.
Checked against official sources: 2026-10
At a glance
What a Certificate of Free Sale is and why buyers ask for it
The UK government describes a Certificate of Free Sale as a document that confirms a product complies with the relevant laws and regulations and can be freely sold on the open market. Importing countries usually request one when they do not have their own regulatory regime for the product, or as part of registering it before the first import.
Because the certificate speaks for the exporting country's rules, it must come from an authority there. Many importing countries also want it legalised or apostilled; for example, China's CCPIT lists free sale certificates among the government-issued certificates it can certify. Ask the buyer early which issuer, wording, product list and legalisation they need.
United States: FDA export certificates
The US Food and Drug Administration issues several export certificates for products it regulates, applied for through its online export certificate application system:
- Certificate to a Foreign Government: for conventional foods, food additives, food contact substances and infant formula that can be marketed in and legally exported from the United States.
- Certificate of Exportability: for products that cannot be legally marketed in the United States but meet section 801(e)(1) of the FD&C Act.
- Certificate of Free Sale: only for dietary supplements, medical foods and foods for special dietary use, with no fee.
- Certificate for Cosmetics: for products that meet the cosmetic definition in section 201(i) of the FD&C Act.
- Health certificates: for collagen and gelatin products for the European Union.
- Fees for most certificates: USD 175 for the first certificate, USD 155 for the second for the same products in the same request, and USD 100 for each further one.
United Kingdom and other examples
UK exporters apply online for a Certificate of Free Sale and other export certificates from the UK government, using a GOV.UK One Login account. For medical devices, the MHRA issues the certificates: the applicant must be a UK-based manufacturer, UK responsible person or Northern Ireland-based authorised representative, the devices must be registered in the MHRA's Device Online Registration System (DORS) with UKCA, CE or CE UKNI marking, and the MHRA aims to process orders within 10 working days.
Other countries have their own issuers for specific products. Singapore's Health Sciences Authority, for example, issues Free Sale Certificates for Chinese proprietary medicines, each for one product and up to five importing countries, as verifiable electronic certificates through FileSG since 25 March 2026.
Step by step
- Ask the buyer or the importing authority exactly what they need: the certificate type, the issuer, the product names and any legalisation or apostille.
- Find the authority that issues it for your product type in your country, for example the FDA in the United States or the MHRA for medical devices in the UK.
- Make sure the product is legally on the market at home first, for example registered or notified where your country requires it.
- Apply with product names exactly as on the labels and the commercial invoice, so the documents match.
- Allow time for processing and, if required, for legalisation or an apostille before the registration deadline.
- Keep copies, since many importing countries ask for a new certificate when it expires or the products change.
Documents you usually need
- Certificate of Free Sale or the authority's export certificate
- Product list with names as on the labels
- Proof of registration or notification at home, where required
- Legalisation or apostille, if the destination asks for it
- Commercial invoice and packing list
Common problems and how to avoid them
What to do: A Certificate of Free Sale comes from the exporting country, because it confirms the product can be sold there.
What to do: Apply with the exact product names used on the labels and documents, or the importing authority may reject it.
What to do: Check before applying whether an apostille or consular legalisation is needed and plan the extra time.
What to do: At the FDA that certificate covers dietary supplements, medical foods and foods for special dietary use; conventional foods use the Certificate to a Foreign Government.
Sources
- Certificates of free sale UK Government (Department for Business and Trade)
- Food export certificates US Food and Drug Administration
- Certificates of free sale for medical devices: registration and use Medicines and Healthcare products Regulatory Agency (MHRA)
- Authentication services China Council for the Promotion of International Trade (CCPIT)
- Free Sale Certificate (Certificate for Exporter of Chinese Proprietary Medicines) Health Sciences Authority (HSA), Singapore
Rules change often. This note is practical guidance based on the sources above, not legal advice. Confirm current requirements with the authority, your importer or a licensed customs broker before you ship.
Trade notes
Common questions
What is a Certificate of Free Sale?
A document confirming that a product complies with the laws of the exporting country and can be freely sold there. Importing countries use it to register or clear products.
Who issues a Certificate of Free Sale?
An authority in the exporting country for the product type, for example the FDA in the United States or, for medical devices in the UK, the MHRA.
How much does an FDA export certificate cost?
Most cost USD 175 for the first certificate, USD 155 for the second for the same products in the same request and USD 100 for each further one; the Certificate of Free Sale for dietary supplements, medical foods and foods for special dietary use has no fee.
How long does the MHRA take for medical devices?
It aims to process orders within 10 working days, longer in busy periods.
Does a Certificate of Free Sale need to be legalised?
It depends on the destination. Many countries ask for an apostille or consular legalisation, so check with the buyer before you apply.
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