Last Updated: October 2026
Every controlled medical device intended to be sold in Mexico must undergo a previous authorization by the Mexican Ministry of Health before its commercialization. The aforementioned authorization is a document called Sanitary Registration, which COFEPRIS (the Mexican FDA) issues after evaluating a set of requirements.
In addition, there are two ways to obtain the Sanitary Registration:
- The ordinary process
- The equivalency agreements
COFEPRIS has determined that the requirements to get the Sanitary Registration of a medical device in Mexico by the ordinary process are similar (Equivalent) to to those evaluated by certain reference regulatory authorities. Hence, COFEPRIS created the equivalency agreements.
In order to be eligible to apply for the equivalency agreement route, a series of requirements must be fulfilled. The most important is to hold a valid approval from a recognized reference regulatory authority eligible under the applicable equivalency agreement, including authorities from Australia, Brazil, Canada (Health Canada), China, the European Union, Japan, Russia, Singapore, South Korea, Switzerland, the United Kingdom and the United States of America (FDA).
There are many perks of requesting a sanitary registry through the equivalency agreement pathway, specifically:
- Less technical and legal documentation is requested by COFEPRIS.
- The review and approval times are shorter
- Reduced translation costs.
However, the equivalency agreement is not exempt of drawbacks. For instance, it could be harder to get the medical device approved in one of the countries listed above.
In addition, the rules in these countries may change and gather the right documentation to be submitted to COFEPRIS can be complicated or time consuming.
Manufacturers should evaluate whether the equivalency agreement route is the most appropriate pathway for their specific regulatory strategy in Mexico.
We would like to recognize Hugo Vite for his contribution to the original version of this article. This content is periodically reviewed and updated by Veraque to reflect regulatory developments.