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AMERICAS
MEXICO
Market Information
Mexico’s healthcare expenditure per person decreased to approximately 1,181 U.S. dollars in 2022, compared to the 1,262 U.S. dollars spent per capita on health in the previous year.
Market Trend: Approximately 59.9% of the population lacks medical insurance. The primary insurance institution is the Mexican Institute for Social Security (Instituto Mexicano del Seguro Social, IMSS), providing coverage for 29.5% of the population. Private insurance agencies extend coverage to 1.5% of the total population.
Mexico’s medical equipment market is expected to show an annual growth rate (CAGR 2024-2028) of 4.70%, resulting in a market volume of US$9.72bn by 2028.
The Secretariat of Health in Mexico (Secretaría de Salud), oversees the formulation of national health policy and various aspects of health services. This includes the regulation of drugs and medical devices. The regulatory framework governing the import and export of medical products and food is defined by the General Health Law, known as "Ley General de Salud" in Spanish.
Classification, Fees, Timeline
Product Registration Routes
Class I, II, III
Expedited Route
(Third Party Route-TPR)
Equivalency Route
(Applicable for all medical devices approved in the US, Canada, and Japan)
Useful Information
Validity of License: 5 years.
License transfer: In Mexico, the transfer of local registration holders is permissible, contingent upon the original holder's agreement. To formalize this transfer, both parties must sign a contract transferring the rights, a process that requires notarization. The agreement explicitly outlines the relinquishment of registration by the original holder. Additionally, a copy of the Registration Certificate, including any modifications made post-approval, must accompany the transfer documentation.
Importer and Distributor: Local License Holder, on behalf of the product owner, is responsible to appoint Importers and Distributors.
