What COFEPRIS requires for the Certificate of Free Sale.

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The Certificate of Free Sale (CFS), also known as “Certificate for Export” or “Certificate to Foreign Government”, is a document to evidence that goods, such as medical devices, are legally sold or distributed without restriction. Ministries of Health from different countries require a Certificate of Free Sale as part of their regulatory evaluation.

 

In this text we will describe the characteristics that a CFS must meet to be accepted by COFEPRIS (Mexico)

 

Regulation in Mexico

 

According to Article 180 of the Health Supplies Regulation, in order to obtain a Sanitary Registration for foreign made medical devices, it is necessary to submit a valid CFS or equivalent document issued by the Ministry of Health from the country of origin.

 

No additional details are established in this regulation regarding the characteristics of the CFS. However, checklists issued by COFEPRIS were available online, and they worked as an acceptable reference for it. Unfortunately, these checklists are no longer published, but we present a summary related to the CFS characteristics:

 

  • Issued by the Ministry of Health of the country of origin.
  • Apostilled or Legalized in the country of origin.
  • If no expiration date is declared, the issuance of the document must be less than 30 months upon submission to COFEPRIS.
  • The document must specify the product, distinctive name, models with codes and/or presentations, the legal manufacturer and manufacturing site.
  • The certificate must state the device is being sold in the country of origin.
  • There are not restrictions to export oversees.

 

Equivalent documents to CFS

 

For those cases where a CFS is not available, there are some documents that might cover the requirement:

 

  • Letter issued by the Ministry of Health of the country of origin stating that these products are not subject to health control.
  • Document of approval issued by the corresponding Ministry regulating medical devices in the country of origin.
  • In case that the manufacturer is a legal manufacturer, and the real manufacturer is located in another site, it is necessary to present a legal document proving the relationship between the parties. It is worth mentioning that the CFS of the country of origin (the real manufacturer)  is still a requirement.

 

 

Equivalence agreement

 

When applying for a registration through the Equivalency Agreement, there are some particular points to consider:

 

 

Special cases

 

There may be some cases when is not possible to meet the above-mentioned requirements. For instance:

 

  • The medical device is not intended to be marketed in the country of origin, and thus a CFS from the country of origin is not available.
  • A different country than the country of origin releases the CFS.

 

These and more cases can be solved with a regulatory strategy that will be different for each situation. If you have more questions regarding CFS and equivalent documents, please contact us at contact@veraqueconsulting.com