Page Last Reviewed: 18 May 2023
A Certificate of Free Sale (CFS) provides evidence that goods, such as medical devices, are legally sold or distributed and eligible for export. For CE marked medical devices, the CFS demonstrates the device meets the regulatory requirements for sale in the European Union.
A CFS is sometimes mandatory for registration in non-European countries. And where it is not mandatory, it can still sometimes be used to help expedite the registration process and allow an abridged review, for example, in India.
For international registration purposes, most regulators require that a CFS be issued by one of the following reference countries: Australia, Canada, European Economic Area (EEA), Japan or the USA. Now that the United Kingdom (UK) and Switzerland are considered ‘third countries’ from the EEA, some international regulators may also accept a CFS from the UK or Switzerland.
Depending on the issuing authority, this type of certificate may also be referred to as a Certificate for Export (COE), Certificate to Foreign Governments (CFG), or Free Sale Certificate (FSC).
European Economic Area
A manufacturer can request a CFS in the country where their business is registered. If the manufacturer is not located in the EEA, then their European Authorized Representative will request the CFS on their behalf. A CFS will only be issued to a European manufacturer or the EU authorized representative. A CFS will not be issued to an importer, distributor, nor to a non-EU manufacturer.
So, if you are a manufacturer located within the EEA, you would request a CFS from your Competent Authority . However, if you are not located in the EEA and Casus Consulting is your Authorized Representative, for example, then Casus Consulting would submit a CFS request to our national competent authority (Irish HPRA) on your behalf.
Generally, each national competent authority’s website outlines their individual process, cost and timeframe to obtain a CFS.
United Kingdom
Same as the EEA, it must be requested either by the domestic manufacturer, or where the manufacturer is not located in the UK, their UK Responsible Person (UKRP).
Switzerland
Same as the EEA and UK, it must be requested either by the domestic manufacturer, or where the manufacturer is not located in Switzerland, by their Swiss Authorized Representative (CH-REP).
The competent authorities in Ireland (HPRA), UK (MHRA) and Switzerland (Swissmedic) all require similar information.
Below are examples of items that are requested. The requirements may vary depending on the national competent authority.
| Legal manufacturer |
Name and address
EUDAMED Single Registration Number (SRN) may be required, depending on the European national competent authority
Swiss Single Registration Number (CHRN) if manufacturer is located in Switzerland |
| Representative: EU Authorized Representative, UK Responsible Person, Swiss Authorized Representative |
Name and address
Proof of appointment may be required depending on the national competent authority.
EUDAMED Single Registration Number (SRN) may be required, depending on the European national competent authority
Swiss Single Registration Number (CHRN) required for Swiss Authorized Representative |
| Proof of conformity assessment, i.e., proof of CE Marking |
Notified Body issued CE Marking Certificate* Approved Body issued UKCA Marking Certificate Declaration of Conformity Proof of device registration may be required, if applicable, depending on the competent authority |
| Physical Manufacturing Site | These details may be mandatory for some competent authorities and optional for others |
| Device Details |
Device Names/Product Codes Basic UDI-DI required for MDR/IVDR CE marked devices Classification GMDN or other nomenclature Copy of the label and IFU for the devices, where applicable. Copies of ISO certification, where applicable. Note: The requirements for the EU may reduce once Eudamed is fully functional as Economic Operators, devices and certificate information will be available |
*The CE Marking certificate must be valid for a minimum of six months when submitted to the Irish HPRA and a minimum of three months when submitted to Swissmedic, or conditions will apply.
It varies by competent authority.
Certificate of Free Sales validity is generally aligned with the expiration date of the Notified Body certificate for the device. Or, if only self-certified devices are listed on the CFS, then generally a standard expiration period is set by the competent authority – for example, 5 years. However, in some cases the competent authority may not issue an expiration date at all, and instead puts the responsibility on the receiving regulatory authority to ensure that CE marking is valid at the time of use.
Another factor is the marketing period for devices under the old Directives. After 31 December 2027 (Class IIb implantable and Class III) and 31 December 2028 (all other classes), MDD CE marking is no longer valid and no further MDD CE marked devices can be placed onto the European market. The IVDR has a progressive rollout, making IVDD CE marking invalid for some devices on 26 May 2022, and others invalid up through 26 May 2027. Some international regulators may not accept a CFS issued past these dates, even if they have not yet expired.
| Authority | Expiration Date |
| UK |
The expiry date on the Certificates of Free Sale will be the earliest expiration date of any Conformity Assessment document, of any device included in the CFS order, plus 365 days
For devices with Declaration of Conformity or Custom-made Statements, the maximum validity will be 5 years |
| EEA – varies |
The Irish HPRA only lists the issue date; no expiration date is printed on the certificate
Other competent authorities may have varying timeframes, e.g., the date the CE Marking certificate expires, or up to x number of years |
| Switzerland | Certificates are valid for 3 years, or 5 years if the country of importation is Thailand |
Many countries in Asia, the Middle East and Latin America require prior approval in a reference market (Australia, Canada, Europe, Japan, or the USA) for medical device registration. A CFS from an EU Competent Authority serves as evidence of this approval and is often included as part of the initial registration application, renewals and/or importations.
The UK and Switzerland may start to be considered reference markets as well, once international authorities have an opportunity to update regulations to reflect the exit of these countries from the EU. For example, if you cannot obtain a CFS from an EU Competent Authority, but can obtain one from the UK MHRA, it may be worth verifying if that would be accepted.
| Competent Authority | Turnaround Time | Format | Fees |
|
Ireland: HPRA
NOTE: the time, format and fees will vary depending on the EU National Competent Authority issuing the CFS |
2-6 weeks | Original document with wet signature | €255 for up to four certificates requested simultaneously, €25 per additional certificate |
| Switzerland: Swissmedic | 30 calendar days | Original document with wet signature |
CHF 200 per certificate Incomplete applications that are not corrected within 30 days are charged CHF 100 and withdrawn. |
| United Kingdom: MHRA | 10 working days | PDF with an electronic signature; MHRA will not issue an original with wet signature |
Certificates cost £75 per order for the first 10 certificates. Additional certificates on the same order cost £10 each. |
Some international regulators require the CFS to be apostilled/legalized. An apostille is a seal that provides evidence that the CFS is authentic. It is only available for Hague Convention countries and only specific agencies can issue the apostille. For example, in the UK it is the Foreign, Commonwealth & Development Office and in Switzerland it is the Federal Chancellery.
Further, the CFS may first need to be notarized before it can be apostilled, such as for Certificates of Free Sale issued in the UK.
If a country is not party to the Apostille Convention, such as China and Vietnam, then the CFS may instead require legalization at the Embassy or Consulate.
This step adds to the turnaround time for a CFS.
Below is an example from UK’s MHRA + sample appendix/schedule:
With the implementation of the MDR and IVDR, some aspects of the Certificates of Free Sale will change:
Another factor to consider is the transition timing between MDD/IVDD and MDR/IVDR CE Marking. For example:
If you have a mix of products CE marked to the old Directive and the new Regulation, you may need several Certificates of Free Sale to cover all products. The EU national competent authorities will not issue a single CFS that includes both Directive/Regulation products. The Swiss competent authority requires a separate application per device group and has a different application form for old legislation (‘legacy’) devices. The UK MHRA may issue a single CFS covering both old Directive and new Regulation products.
Further, a Certificates of Free Sale issued with MDD devices may not be accepted by some international regulators after 31 December 2028, since as of that date MDD CE marked devices can no longer be legally placed onto the market. For the IVDD, due to the progressive rollout, CE marking validity ends between 26 May 2022 and 26 May 2027, depending on the classification of the device.
