All documents listed below are available from the South African Department of Health. Electromedical devices fall under the scope of the Hazardous Substances Act, No...
Medical Device Regulatory Strategy Report in Mexico
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.
Certain low risk devices are exempt from registration requirements in Mexico, and others are eligible for a simplified registration process.
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 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