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