Medical Device Regulatory Strategy Report in Mexico

Registering your medical device for sale in Mexico requires approval from the Federal Commission for Protection from Sanitary Risks (COFEPRIS), a division of Mexico’s Ministry of Health. Some devices that have previously obtained market authorization in the US, Canada, or Japan qualify for expedited review by COFEPRIS.

Certain low-risk devices are exempt from registration requirements in Mexico, and others are eligible for a simplified registration process.

Let Emergo by UL assist you in evaluating the Mexican medical device regulatory framework as it applies to your device(s).

Through our global network of in-house consultants, industry contacts, and regulatory sources, Emergo provides in-depth coverage of multiple medical device markets, including Mexico. Our Regulatory Pathway reporting service for Mexico includes:

  • Regulatory background for COFEPRIS
  • Product assessment, including classification and registration routes
  • In-country representation requirements
  • Medical device registration requirements
  • Labeling and language requirements
  • Costs and timeframes
  • Mexico regulatory roadmap
  • Ongoing compliance

Please contact us for more information about our Regulatory Strategy Report for Mexico approval.

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