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A certificate of free sale for medical devices is an official document, issued by a regulator, that states a device may be legally sold in the issuing country or region. Importing countries often ask for one before they accept a foreign device. This guide explains who issues it, what it does and does not prove, and how a buyer can check one. It describes documents and general regulatory practice; it is not legal advice.
What a certificate of free sale is
A certificate of free sale (CFS) is a government-issued statement that a device is legally marketed in the issuing jurisdiction. The UK regulator (MHRA) says that you “may need” one and that you should check the import rules of the destination country. The Austrian regulator (BASG) says a CFS may be required to export CE-marked devices and in vitro diagnostics outside the EU. Whether a given destination requires one is set by the destination, not by the exporter.
FDA: why the US document is a CFG, not a CFS
The US FDA does not use the phrase “certificate of free sale” on its export-certificate pages. Its equivalent for a legally marketed device is the Certificate to Foreign Government (CFG). FDA states that devices which can be legally marketed in the US and comply with the Federal Food, Drug, and Cosmetic Act may be exported anywhere in the world without prior FDA notification or approval; the CFG is the document a foreign buyer or authority may ask for as evidence of that status. If a purchasing contract asks for a “certificate of free sale” from a US manufacturer, the document to request is usually the CFG.
FDA lists these CFG eligibility points: the establishment is registered and the device is listed; the device has 510(k) clearance, PMA approval (unless exempt), pre-1976 status or a De Novo grant; labeling meets 21 CFR 801 and 809 where applicable; and the device is made under the quality management system regulation (21 CFR 820) unless exempt. For background on registration and listing, see FDA-registered medical devices.
Which FDA export certificate applies
FDA’s Center for Devices and Radiological Health issues four types of export certificate. They are not interchangeable, and only the first states that the device is legally marketable in the US.
| Certificate | Covers | Key difference |
|---|---|---|
| Certificate to Foreign Government (CFG) | Devices that can be legally marketed in the US | Closest to a certificate of free sale |
| Certificate of Exportability, section 801(e)(1) | Class I or II devices not legally marketable in the US | Export only |
| Certificate of Exportability, section 802 | Certain unapproved Class II or III devices | Not a statement of US marketability |
| Non-Clinical Research Use Only (NCR) | Products for non-clinical research use only | Not for clinical use |
Source: FDA, Types of Export Certificates, checked 2026-11-01. A fifth variant, the CFG for devices not exported from the US (CFG-NE), covers devices made by a registered and listed establishment outside the US that are US-authorized and imported into the US. It is requested on Form 3613g by answering “No” to whether the devices will be exported from the United States, and it requires that there is no open import alert, recall, seizure or injunction.
UK and EU: who can apply
United Kingdom
The MHRA issues the UK certificate. Applicants are a UK-based manufacturer, a UK responsible person, or a Northern Ireland-based authorised representative. Devices and IVDs must be registered through the MHRA’s DORS system and carry a UKCA, CE or CE UKNI mark. A Great Britain certificate covers a UKCA-marked device freely sold in Great Britain; a Northern Ireland certificate covers a CE-marked device sold freely in the UK and EEA, and CE UKNI devices are covered for the UK only. IVDs for performance evaluation are excluded. The MHRA aims to issue within 10 working days, which may be longer.
Austria (EU example)
The Austrian BASG issues a CFS under Article 60 of the MDR or Article 55 of the IVDR (Articles 120 and 110 for devices still under the Directives). Only a manufacturer or authorised representative based in Austria can request one. Systems and procedure packs cannot receive a CFS, the wording follows the business-register entry, one request can list up to 500 products, validity is up to two years, and legalisation is a separate step. Documents are generally in German. For the marking itself, see what CE marking means.
What it proves and what it does not
- It proves the regulator’s statement about marketing status in its own jurisdiction on the listed devices.
- It is not a government endorsement of the product, and the MHRA states that it does not verify that the product meets the destination country’s requirements; that remains the applicant’s responsibility.
- It is not a certificate of origin, which records where goods were made. See certificate of origin.
- It is not a quality system certificate. For that, see ISO 13485 certification.
How a buyer verifies one
These steps come from the regulators’ own procedures.
- Ask which authority issued the document and under which name it is issued there (CFS, CFG or another).
- Check that the product list names the exact devices you are buying. The Austrian CFS excludes systems and procedure packs, and FDA applications list product code and marketing status per device.
- For an FDA certificate: since 2 January 2024 certificates are downloadable PDFs that can be authenticated with the FURLS Export Certificate Validator (FECV), through the web address or QR code printed on the certificate, for the time the certificate is in effect.
- For a UK certificate: the FCDO does not authenticate CFS PDFs; a notary checks the certificate with the MHRA and can notarise it if the destination requires.
- For an Austrian certificate: check the validity period (up to two years) and whether the destination also requires legalisation. See also vendor onboarding documentation and finding a medical supply manufacturer.
Common mistakes
- Asking a US manufacturer for a “certificate of free sale” and accepting a Certificate of Exportability, which does not state US marketability.
- Assuming the document confirms the device meets the importing country’s rules.
- Accepting a certificate that lists a different device or manufacturer than the one supplied.
- Treating a CFG for a device made outside the US as an export from the US; the CFG-NE route exists for that case.
Frequently asked questions
What is a certificate of free sale for medical devices?
A regulator-issued document stating that a device is legally marketed in the issuing jurisdiction, often requested by the importing country.
Does the FDA issue a certificate of free sale?
Not under that name. FDA issues a Certificate to Foreign Government (CFG) for devices that can be legally marketed in the US.
Who issues a certificate of free sale in the UK?
The MHRA, to a UK-based manufacturer, a UK responsible person, or a Northern Ireland-based authorised representative, for devices registered in DORS.
How long is an Austrian certificate valid?
Up to two years, according to BASG.
Sources
- FDA, Types of Export Certificates, checked 2026-11-01.
- FDA, How to request export certificates, checked 2026-11-01.
- FDA, Devices Not Exported from the United States, checked 2026-11-01.
- GOV.UK / MHRA, Certificates of free sale for medical devices, checked 2026-11-01.
- Austrian Federal Office for Safety in Health Care (BASG), Certificate of Free Sale, checked 2026-11-01.
