Every controlled medical devices 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 and the equivalency agreement.
On the other hand, 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 that needed for approval of a medical device in the United States of America, Canada or Japan respectively. 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 either the Food and Drug Administration (FDA), Health Canada or the Ministry of Health Welfare and Labor depending on which country the medical device has been approved for its marketing.
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.
It is important to notice that this kind of requests are not eligible to be reviewed by an authorized third party. Therefore, COFEPRIS will review them directly with more strict criteria and the documents and information submitted must be correct to avoid delays and take advantage of this fast track route.
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We want to thank Hugo Vite for his support on writing this document.