How to get a Certificate of Free Sale in 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).

Who can request a Certificate of Free Sale?

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).

What information is required in the application?

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.

What information is typically included on a CFS?

Name and address of the manufacturer
Name and address of the authorized representative, where appropriate
Name and address of the manufacturing site, where appropriate
Details of the Basic UDI-DI
Details of the EU Declaration of Conformity, such as the legal framework (MDD/MDR) and date of issue
Details of the EC Certificate, such as Notified Body identification, Certificate Number, legal framework (MDD/MDR), date of issue and validity (where appropriate)
The country can be identified on the CFS, if you request it. However, you can usually also request to not list a specific country.
- It is important to research the requirements of the country where you are registering your devices. For instance, the Kingdom of Saudi Arabia requires their country to be listed on the certificate. If your company completes a lot of international registrations and are in a constant state of new registrations and renewals, you may choose to procure Certificates of Free Sale with no country identified, to use in countries that do not require to be identified.
Signature or Stamp from the issuing Competent Authority

What devices can be grouped together on a single CFS?

A single CFS can cover both self-certified and Notified Body CE marked devices, however, it is up to the national competent authority to choose if they will do so.
A CFS issued under Article 60 may only be issued for MDR CE marked devices. Therefore, separate certificates must be issued for MDD and MDR CE marked products.
A CFS will not be issued to System and Procedure Pack Producers (SPPP). This is because a system/procedure pack is not a device as outlined by Article 1(4) of the MDR and is typically not CE marked; therefore the SPPP is not a manufacturer of a device.

Do Certificates of Free Sale expire?

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	For MDR/IVDR/IVDD devices, the Irish HPRA only lists the issue date; no expiration date is printed on the certificate. For MDD/AIMDD devices that qualify for the extension under Regulation 2023/607, the HPRA will introduce a three-year expiration date. If the device does not qualify for the extension, the expiration date will be set for May 2024. 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

Where is a CFS commonly needed?

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.

What is the turnaround time for a CFS?

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.

Does the CFS require apostille/legalization?

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.

What does a CFS look like?

Below is an example from UK’s MHRA + sample appendix/schedule:

How does the MDR/IVDR impact Certificates of Free Sale?

With the implementation of the MDR and IVDR, some aspects of the Certificates of Free Sale will change:

- Will refer to the new Regulations, instead of the old Directives
- Will include the BASIC-UDI-DI
- Will include the Notified Body’s CE Marking certificate number, when applicable
- MDR Article 60 & IVDR Article 55 notes that the EU Commission may develop a ‘model’ for the certificates, i.e., the format of the document may become more standardized

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.

Certificates of Free Sales for Medical Devices: Europe, UK and Switzerland

Update: IVDR progressive roll-out approved

EU Guide: Basic UDI-DI

What is a Certificate of Free Sale?