Mexico is a major Latin American market with significant growth in healthcare, pharmaceuticals, and medical devices, offering strategic access to North and Latin American markets.
The Federal Commission for the Protection against Sanitary Risk (COFEPRIS – Comisión Federal para la Protección contra Riesgos Sanitarios) is the national regulatory authority responsible for the registration, importation, distribution, quality control, pharmacovigilance, and post-market surveillance of medicines, medical devices, biologics, cosmetics, and related health products in Mexico. COFEPRIS requires product registration, import permits, GMP compliance, quality certificates (CPP, GMP), Spanish labelling, and often local representation or a Mexican sanitary registration holder. MedWisdom LifeScience provides expert regulatory affairs support to help global manufacturers navigate COFEPRIS requirements, prepare compliant dossiers, secure timely approvals, and achieve efficient market entry and sustained compliance in this key Latin American market.
Get Mexico Compliance Support
Preparation of regulatory dossiers (CTD/eCTD format), supporting documents (stability, preclinical/clinical data, GMP/CPP certificates), and quality review for COFEPRIS submissions.
End-to-end support for COFEPRIS registration of medicines, biologics, medical devices, and health products in Mexico.
Assistance with COFEPRIS import/export authorizations, sanitary import permits, batch release certificates, and customs documentation.
Guidance on Mexican GMP requirements, quality assurance documentation, certificate support, and preparation for COFEPRIS inspections.
Setup of pharmacovigilance systems, adverse event reporting to COFEPRIS, periodic safety reporting, and risk management in Mexico.
Support for post-market monitoring, vigilance reporting, field safety corrective actions, and compliance with COFEPRIS post-registration requirements.
Spanish labelling review, COFEPRIS-specific requirements (patient information, packaging), mock-up preparation, and compliance support.
Support for local sanitary registration holder/agent requirements, COFEPRIS liaison, regulatory follow-up, and ongoing compliance management in Mexico.
Strategic market entry planning, COFEPRIS pathway guidance, regulatory intelligence on Mexico’s requirements, and risk mitigation support.
Partner with Medwisdom for expert, reliable, and compliant regulatory support in Mexico — from COFEPRIS product registration and import permits to pharmacovigilance, Spanish labelling, and sustained Latin American market access.
Contact Our Mexico Regulatory Experts