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.
Through our global network of in-house consultants, industry contacts and regulatory sources, Emergo Group provides in-depth coverage of multiple medical device markets, including Mexico. If you would like to see what these reports include, you may download a sample Regulatory Overview Report.
Our Global Regulatory Overview reporting service for Mexico includes: