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.
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:
|Egypt||Peru||United Arab Emirates|
Emergo Europe acts as Authorized Representative for hundreds of medical device companies selling their products in Europe. In this capacity, Emergo Europe can request a CFS from the Competent Authority in The Netherlands as efficiently and quickly as possible: