Several nations around the world require manufacturers to submit a Certificate of Free Sale, which is also known as “Certificate to Foreign Governments” or “Certificate for Export”. This certificate of free sale acts as evidence that certain goods, like medical devices, biologics, cosmetics, or food items have the approval of regulatory authorities present in exporting country (the USA) and can be sold/distributed legally without any restrictions in the open market.
The Certificate of Free Sale or CFS is extremely important for medical instrument manufacturers who need to carry out their business across borders. CFS happens to be an extra requirement for manufacturers to make sure that their devices are freely available for sale in the exporting country’s market (this refers to the manufacturer’s home country).
CFS verifies that the medical device has been approved for usage in the exporting country. If the medical device has been manufactured within the EU, manufacturers must ensure that the Certificate of Free Sale endorses the fact that the medical device to be exported has a CE marking.
A representative acting on the manufacturer’s behalf can file an application with the European Competent Authority to facilitate the issuance of CFS.
What Purpose Does the Certificate of Free Sale Serve?
Medical instrument manufacturers looking to enter international markets cannot move forward without CFS. For medical product manufacturers based out of the EU, CFS has a huge role to play in helping them capitalize on various opportunities in the Middle East as the healthcare sector there is in dire need of different medical instruments, which are commonplace across the EU.
How Is the Manufacturer Verified?
While there are numerous ways to verify the authorization of the manufacturer, CFS offers conclusive proof about the possession of a valid medical license by the manufacturer. Authenticating the manufacturer’s license automatically verifies that the company is in compliance with the guidelines applicable for CE marking.
How Is the Product Verified?
Since importing countries generally want to ensure strict health and safety standards in their medical industry, they will not permit the usage of pharmaceutical products, medical devices, and other important healthcare products from manufacturers who are incapable of furnishing satisfactory proofs that their medical products have been authorized for usage within the country they’re based out of.
Therefore, CFS happens to be a critical document in which competent regulatory bodies vouch for the credibility of the importing manufacturer and verify that their medical devices have been certified and authorized for usage in the manufacturing country.
Verification of GMP Compliance
The CFS document also verifies that the medical device is in compliance with the Good Manufacturing Practice guidelines issued by the International Society for Pharmaceutical Engineering. CE marking aside, this is another crucial certification that authenticates the validity of the medical product in question.
CFS essentially serves as a guarantee given by the country importing the device to the country exporting the device regarding the authenticity and legitimacy of the product and its manufacturer.