Registering your medical device for sale in Mexico requires approval from the Comisiόn Federal para la Protecciόn contra Riesgos Sanitarios (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.
Let Emergo 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 Global Regulatory Overview reporting service for Mexico includes:
- Regulatory Background for COFEPRIS
- Product Assessment, including classification and applicable registration route
- In-Country representation requirements
- Medical Device Registration requirements
- Costs and Timeframes
- Labeling and Language Requirements
- Mexico Regulatory Roadmap
- Ongoing compliance