MexicO
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.



ARE YOU INTERESTED IN REGISTRATION 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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  • Phone +1 604.681.6888
  • Fax +1 604.681.6822
  • info@arazygroup.com
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  • #350-1333 Johnston Street
  • Pier 32, Granville Island
  • Vancouver, British Columbia
  • Canada V6H 3R9

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