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Medical devices are regulated by COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios).
Devices are classified according to risk, similar to the EU system.
The approval process takes approximately one year for the standard process, but only 4-5 months under the fast-track system.
Licenses issued in Mexico expire after five years.
An authorized representative is required.
The licensing process is expedited for devices which have already been approved in Canada or Japan.
Last updated on February 9 2015.
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For more information on registration in Mexico, check out the following articles on our blog:
Country at a Glance: Mexico
5 Questions and Answers: Just How Fast Is Mexico's Fast Track Process?