Obtaining a Certificate of Free Sale (CFS) for Medical Devices

Many medical device market regulators around the world require foreign manufacturers to provide a Certificate of Free Sale (CFS) showing that their products are approved for sale in Europe. In these markets, your CFS must be presented to authorities as part of your registration process. Emergo Group has obtained CFS documents for many clients seeking medical device registration in Asian, Middle Eastern and Latin American markets, and can procure a CFS on your behalf for your medical device.

How to Procure a CFS for your medical device

A CFS is issued by a European Competent Authority upon request by an Authorized Representative on behalf of a medical device manufacturer. The CFS certifies that your medical device may be legally marketed in the European Union. Based in the Netherlands, Emergo Group’s Authorized Representative service (Emergo Europe) can request CFS documents from the Dutch Healthcare Inspectorate on behalf of our clients. Medical device markets for which Emergo Group has secured CFS documents for clients include:

Argentina India Qatar
Australia Iraq Russia
Bolivia Israel Saudi Arabia
Brazil Japan South Korea
Chile Jordan Sri Lanka
China Lebanon Syria
Colombia Mexico Taiwan
Ecuador Oman Thailand
Egypt Peru United Arab Emirates

Emergo Group has the resources and experience to secure your CFS

We act as Authorized Representative for hundreds of medical device companies selling their products in Europe. In this capacity, we can request a CFS from the Competent Authority in The Netherlands as efficiently and quickly as possible:

  • We have offered European Authorized Representative services since 1997
  • We are present in both Europe and many of the markets that require a CFS
  • Our established contacts in the Dutch Competent Authority ensures efficient CFS procurement

Please contact us for more information on our Certificate of Free Sale (CFS) service for European Authorized Representative clients.