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, 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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