Certificate of free sale and medical devices

In June 2022, the Competent Authority for Medical Devices (CAMD) network published an FAQ on Certificates of Free Sale (or CFSs). This is an opportunity to clarify several points for economic operators who wish to obtain such certificates.

Regulation of the certificate of free sale

For health products, CFSs are intended for the health authorities of importing countries outside the European Union.

For medicines, pharmaceutical raw materials (PMP), medical devices (MD) and in vitro diagnostic medical devices (IVDD), they are currently issued by the Paris Region Chamber of Commerce at the request of French exporting companies.

For cosmetics, the competent bodies are FEBEA and COSMED.

Required by various countries, CFSs facilitate the penetration of health products, already on free sale in the EU, on foreign markets. It is the assurance for these countries to benefit from products that comply with European standards. 

Long unregulated, these certificates are now legally provided for DMs in Article 60 of Regulation (EU) 2017/745 and for IVDs in Article 55 of Regulation (EU) 2017/746 of 5 April 2017 .

New CAMD clarification on the Certificate of Free Sale

As a result of these regulations, CAMD has seen fit to provide several clarifications for DM/DMDIV companies, including the following:

• The responsible for issuing CFSs is the Member State in which the manufacturer or the authorised representative has its registered office
• CFSs are issued exclusively to manufacturers or agents
• Consequently, they cannot be issued to producers of systems and kits, nor to distributors or importers
• CFSs for older devices are issued under the applicable directive
• They can be submitted until May 2024 for devices that comply with the directives
• Electronic signatures are allowed

You will then have to follow the many instructions given by the CCI Paris Ile-de-France.