Obtaining a Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG)

Some medical device market regulators require documentation from foreign manufacturers known as Certificates of Free Sale (CFS) or Certificates to Foreign Governments (CFG).

A CFS is issued by an EU Competent Authority upon the request of an authorized representative on behalf of a manufacturer. The CFS certifies that the medical device can legally be marketed in the EU. Emergo Group’s Authorized Representative service is based in the Netherlands, and can request CFS documents from the Dutch Healthcare Inspectorate on behalf of our clients.

A CFG is issued by the US Food and Drug Administration (FDA), and confirms that a medical device can be legally marketed in the US.

Emergo Group has procured CFS and CFG documents for numerous medical device clients seeking registration in Asian, Middle Eastern and Latin American markets, and can fully support your efforts to secure a CFS or CFG for your medical device. Medical device markets for which Emergo Group has obtained Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG) 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

 

Please contact us for more information on CFS or CFG procurement services we can provide as part of your medical device registration process.


Note that we can only provide CFS and CFG procurement services to Emergo Group clients.