Mexico

In Mexico, the primary regulatory authority for health products is COFEPRIS, which operates under the Secretaria de Salud (SSa) and is governed by the General Health Law (Ley General de Salud) along with its associated regulations, including the Regulation on Health Inputs (Reglamento de Insumos para la Salud). COFEPRIS is responsible for the evaluation, registration, and post-market surveillance of pharmaceuticals, medical devices, diagnostics, and digital health solutions. All health products intended for commercialization in Mexico must obtain a Sanitary Registration (Registro Sanitario) or, in some cases, a Sanitary Authorization, prior to market entry. The review process involves technical dossier evaluation, facility inspections, and, for pharmaceuticals, bioequivalence or clinical data requirements depending on the product class.

Applicants must appoint a local legal representative or sponsor (Responsable Sanitario) who is accountable to COFEPRIS throughout the product lifecycle. Mexico generally accepts dossiers structured according to the Common Technical Document (CTD) format, particularly for pharmaceuticals, and is increasingly aligning with international standards through its participation in the Pan American Network for Drug Regulatory Harmonization (PANDRH) and collaboration with bodies such as the International Medical Device Regulators Forum (IMDRF). In recent years, COFEPRIS has undergone significant institutional reforms, including efforts to reduce review backlogs and improve transparency. A notable development is the recognition pathway for products already approved by stringent regulatory authorities (SRAs) such as the FDA, EMA, or Health Canada, which can expedite local registration timelines. Digital health products and software as a medical device (SaMD) are an emerging regulatory area, with guidance still evolving.

Public procurement of health products in Mexico is managed through a multi-layered structure involving the Secretaria de Salud (SSa), the Instituto Mexicano del Seguro Social (IMSS), the Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado (ISSSTE), and, since 2020, the Centro Nacional de Programas Preventivos y Control de Enfermedades (CENAPRECE) and the Oficina de las Naciones Unidas de Servicios para Proyectos (UNOPS), which has played a central role in consolidated federal purchasing. Federal procurement is governed by the Ley de Adquisiciones, Arrendamientos y Servicios del Sector Publico (LAASSP), which mandates public tenders (licitaciones publicas) as the standard procurement mechanism, with exceptions for direct awards and restricted tenders under specific conditions. The government has progressively consolidated purchasing to achieve economies of scale, most notably through the national consolidated tender model coordinated by IMSS on behalf of multiple public institutions. State-level health systems (Servicios Estatales de Salud) may conduct independent procurement for locally administered programs, creating a parallel subnational procurement channel alongside federal mechanisms.

The private sector represents a significant and growing share of health product consumption in Mexico, operating through distributor networks, pharmacy chains such as Farmacias del Ahorro and Farmacias Guadalajara, and private hospital groups, with pricing governed by market dynamics rather than regulated schedules. International donor and procurement channels play a more limited role compared to lower-income markets, though organizations such as UNICEF, PAHO revolving funds, and the Global Fund have historically supported procurement for specific disease programs including HIV, tuberculosis, and maternal and child health. Mexico does not have a formal local manufacturing preference policy equivalent to some other markets, but government discourse and post-pandemic industrial policy have increasingly emphasized the strategic importance of domestic health product manufacturing capacity, with incentives under discussion to attract pharmaceutical and device production investment.