COFEPRIS

COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) is Mexico's health regulatory agency, equivalent to the FDA in the United States. It operates under the Ministry of Health (Secretaría de Salud) and is responsible for protecting the population from health risks.

COFEPRIS responsibilities:
- Medical device registration and surveillance
- Pharmaceutical drug approval
- Food and beverage safety
- Tobacco and alcohol control
- Chemical and environmental health risks
- Advertising of health products

Medical device classification in Mexico:
- Class I - Low risk (notification)
- Class II - Moderate risk (registration)
- Class III - High risk (registration with clinical data)

Registration requirements:
- Foreign manufacturers must appoint a Mexican Registration Holder (MRH)
- Certificate of Free Sale from country of origin
- Good Manufacturing Practice (GMP) certificate
- Technical file in Spanish
- Mexican labeling requirements

Key regulations:
- NOM-241-SSA1-2012 - GMP for medical devices
- NOM-137-SSA1-2008 - Labeling requirements
- Various specific NOMs for device categories

Registration timeline: Typically 4-8 months depending on device class.

Mexico is the second-largest medical device market in Latin America and a key entry point for companies targeting the LATAM region.