FDA Thailand Certificate of Free Sale (CFS) for Thai FDA filings: who issues it and what it must say
What is a Certificate of Free Sale?
A Certificate of Free Sale for Thai FDA filings is a document issued by a government authority in the country of manufacture (or sale) confirming that a specific product is lawfully made and sold there. Thai regulators use it as early evidence that the product is not an export-only item that nobody at home supervises.
For anyone working with the Thai Food and Drug Administration, the CFS matters in two directions. Importing: a Thai importer obtains a CFS from the foreign manufacturer to support certain product filings. Exporting: a Thai manufacturer obtains a CFS from the Thai FDA to send to buyers or regulators abroad. This guide covers both, citing the actual Thai notifications and FDA orders.
One point to keep in mind from the start: a CFS is not a Thai marketing authorisation. Holding a CFS from the home country does not let a product be sold in Thailand. The importer still has to complete the route set by Thai law for that product type, such as cosmetic notification or a food serial number. The CFS is one supporting document in that file.
When Thailand asks for a CFS, by product type
Each Thai law names its documents differently. This summary is based on the documents in this site's regulation library.
| Product type | Is a CFS in the import file? | Source |
|---|---|---|
| Dietary supplements | Listed as evidence for imported products, together with a certificate of the manufacturing site | Thai FDA notification on documents for supplement label approval (2006) |
| Cosmetics | Not in the general notification document list; the importer instead needs an authorisation letter from the brand owner or manufacturer | MOPH notification on cosmetic notification, 2018, annex |
| Medical devices | Required for certain device groups, together with quality-system evidence | Thai FDA regulation of 2007 on certificates for importing medical devices |
| All health products | Common rules on who issues a CFS, what it states and how long it stays valid | Thai FDA Order No. 398/2544 (2001) and its amendments |
For supplements there is a nuance. The 2006 Thai FDA notification lists a site certificate and a Certificate of Free Sale for imported products, while the Thai FDA's revised 2026 supplement guide lists a shorter core submission. In practice, prepare the CFS from the start: officers frequently request it, and obtaining one from a foreign authority takes time.
Who may issue a CFS
A frequent question is whether any organisation can issue a CFS. It cannot. Thai FDA Order No. 122/2548 (2005) clarified that the certificate must be issued or endorsed by the government authority responsible for regulating that type of health product, or by a private body recognised by that government.
In practice, a CFS for a supplement should come from the authority that supervises food or supplements in that country. For medical devices, the 2007 regulation requires a government authority of the manufacturing country or a private body that government recognises. Documents from organisations with no regulatory role over the product, such as general trade associations, are likely to trigger questions.
The original 2001 order also allows a certificate from the country of sale rather than the country of manufacture in some cases, where the seller holds evidence of the manufacturing source. If a product is made in one country and the brand owner sits in another, agree early on which country's certificate you will use and how it links back to the factory.
What a CFS must state
Under Thai FDA Order No. 398/2544, a CFS should at minimum show the following. Use it as a pre-submission checklist.
- The product name as it will be filed in Thailand. If the trade name at home differs, the certificate must confirm it is the same product.
- The manufacturer's name and the manufacturing site address, which should match the GMP or equivalent certificate filed alongside.
- A statement that the product is sold in the issuing country.
- The issuing authority, an authorised signature and the date of issue.
One certificate may cover several products under the order's conditions, but check every product name character by character against the Thai application. Small differences, such as a hyphen, a space, or Serum versus Essence, are a common reason for a request for more documents.
Validity, language and legalisation
A CFS is valid for the period it states. If no validity is stated, Order No. 398/2544 requires it to be filed within two years of issue. The 2007 medical device regulation takes a similar line: without a stated expiry, the certificate must be no more than two years old.
Documents not in English need a certified Thai or English translation, so allow time for this if the certificate is in Chinese, Korean or Japanese.
Consular legalisation rules have changed. Order No. 477/2549 (2006) exempted drug CFSs from endorsement by Thailand's foreign ministry or commercial offices, and Order No. 741/2567 (2024) cancelled clause 5 of the original requirements, the clause on consular legalisation, for CFSs supporting health product imports. Do not assume every certificate must go through an embassy, but check the copy-certification rules of the division you file with, because other supporting documents may have their own requirements.
Certificate of Free Sale sample: what a usable one looks like
Formats vary by country, but acceptable certificates share a common structure. Compare the one you receive against this table.
| Field | What you should see | Check it against |
|---|---|---|
| Header | Issuing government authority and the title Certificate of Free Sale | Does that authority regulate this product type? |
| Manufacturer | Legal entity name and factory address | The GMP / ISO certificate filed with it |
| Products | Trade name and product name, one by one | The Thai application and label |
| Statement | That the product is sold in the issuing country | A free-sale statement, not just proof of company registration |
| Dates | Date of issue and expiry if any | No expiry: file within two years of issue |
| Signature and seal | Authorised official | Copies certified as the filing division requires |
Documents often confused with a CFS include a certificate of incorporation, a Certificate of Origin used for customs, and a certificate of analysis. Each has a role, but none certifies free sale, so none can replace a CFS.
Thai FDA certificate of free sale for exporters
If you manufacture in Thailand and export, the Thai FDA can issue certificates.
Cosmetics
The 2019 MOPH notification on cosmetic certificates lets the notification holder apply on form R.K.1 at the Thai FDA or through its electronic system. Six types are available: CFS, CFS with formula, CFS for export to China, CFS with formula for export to China, Certificate of Product Origin, and Certificate of Manufacturer. The product must already be notified, and names in the application must be in English. The 2019 notification replaced the 2018 version.
Food and supplements
The Thai FDA's public guide on export certificates for food lists three types: Certificate of Manufacturer, Certificate of Free Sale and Certificate of Ingredient. The applicant needs a valid, non-suspended manufacturing or import licence, and the Free Sale and Ingredient types require a food serial number. Applications go through e-Submission and certificates are issued electronically. Export-only products without a serial number can still obtain some types by providing the formula, product details and process. See also health certificates for Thai food exports.
Certificate of free sale for medical devices in Thailand
Medical device imports follow a specific Thai FDA regulation from 2007 on certificates for importing medical devices. Its CFS points are:
- The certificate must come from a government authority of the manufacturing country or a private body it recognises, and must still be valid.
- It must show the manufacturer, the site and the product list, with a statement on sale in that country.
- For CE-marked devices, an EC Certificate or EC Declaration of Conformity may be used under the stated conditions.
- Certain groups, such as implants, radiation equipment, test kits and disinfectants, also need quality-system evidence such as ISO 13485.
The Thai device authorisation system has been restructured several times, so confirm with the Medical Device Control Division whether the 2007 criteria still apply as written or have been supplemented before you file.
Checklist before you submit a CFS
- Issued by the government authority that regulates this product type, or a body it recognises.
- Product names match the Thai application and label exactly, or the certificate confirms they are the same product.
- Manufacturer name and address match the manufacturing-system certificate.
- Contains a free-sale statement, not just company registration.
- Still valid, or no more than two years old if no expiry is stated.
- Non-English documents have a certified Thai or English translation.
- Copies are certified as the filing division requires.
Our import document checker reads manufacturer documents and compares product and manufacturer names across them, and the import readiness checker tells you which document set your product needs. For a full pre-filing review, see our import service.
Frequently asked questions
How is a CFS different from a Certificate of Origin?
A CFS certifies lawful sale in the issuing country. A Certificate of Origin certifies where goods come from for customs. They are not interchangeable.
Do cosmetics imported into Thailand need a CFS?
The general cosmetic notification document list does not include a CFS. The importer must attach an authorisation letter from the brand owner or foreign manufacturer. Export-only notifications made to a buyer's specification need evidence from the partner country's government.
How long is a CFS without an expiry date valid?
Under Thai FDA Order No. 398/2544, a certificate without a stated validity must be filed within two years of issue.
Must every CFS be legalised by an embassy?
Not by default. Order No. 741/2567 cancelled the consular legalisation clause in the original CFS requirements. Still check the copy-certification rules of the division you file with.
Can a Thai manufacturer get a CFS from the Thai FDA?
Yes. Cosmetics use form R.K.1 for notified products; food uses e-Submission for a Certificate of Manufacturer, Free Sale or Ingredient.
Sources
- Thai FDA notification on evidence for supplement label approval and pathogen standards (2006) · Open source · Search our archive
- Thai FDA Order No. 398/2544 on Certificates of Free Sale for health product imports · Open source · Search our archive
- Thai FDA Order No. 122/2548 on CFS (No. 2) · Open source · Search our archive
- Thai FDA Order No. 477/2549 on CFS (No. 3) · Open source · Search our archive
- Thai FDA Order No. 741/2567 on CFS (No. 4) · Open source · Search our archive
- MOPH notification on cosmetic notification and certificates of notification, 2018 · Open source · Search our archive
- MOPH notification on applications for and issue of cosmetic certificates, 2019 · Open source · Search our archive
- Thai FDA public guide: export certificates for food premises and products · Open source · Search our archive
- Thai FDA regulation of 2007 on certificates for importing medical devices · Open source · Search our archive
This article is for general information. It is not a Thai FDA ruling or legal advice, and rules change — check the latest notification or ask an expert before filing or producing.