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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