Medical Device Registration and Approval in Mexico

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

Medical Device Regulations and Classification in 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.

For more information on Medical Device Registration in Mexico, check out the following articles:

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