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.