SUBMIT INQUIRY
MexicO
General country-specific regulatory information is provided on this page. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, free of charge, to expedite the preparation of your medical device or IVD registration application.

REGULATORY AUTHORITY:
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.

Last updated on February 9 2015.



Interested in obtaining fast market approval for your medical device or IVD in Mexico? REQUEST A FREE QUOTE>

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?
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