In a previous article, we explained what a Certificate of Free Sale (CFS) is, and the requirements of COFEPRIS for this document when issued abroad. As a side note, this document can also be known as Free Sales Certificate (FSC), Certificate of Foreign Government (for the case of the US FDA) and other similar names.
In this article, we briefly talk about the CFS issued by COFEPRIS for medical devices approved in Mexico. This is particularly interesting, for those Mexican medical device companies looking to export their products to other countries. It is worth mentioning, that this certificate is not granted for medical devices manufactured outside Mexico or for non-regulated products.
Certificate of Free Sales released by COFEPRIS
As any other National Regulatory Agency (NRA), COFEPRIS issues Certificates of Free Sales to allow national manufacturers meeting other agencies requirements, or as part of the importation process in the country of destination.
For medical devices, COFEPRIS issues the Certificate of Support to Export Health Supplies. This certificate is applicable for products meeting the Mexican regulatory requirements, and that are authorized to be sold in Mexico.
As mentioned, this certificate is generally used as part of the regulatory authorization process outside Mexico. However, even if it is not required by the Sanitary Authorities of other countries, it still provides confidence to buyers that the Mexican product is in full regulatory compliance and has proven safety and efficacy –a way to facilitate the health supplies exportation. That being said, the general requirements for this Certificate are as follows:
- Official Application Format (using the application code: COFEPRIS-05-016-C)
- Copy of the Sanitary Registration, aligned with the manufacturing conditions at the moment of the application
- Formula (when applicable)
- Last production order