Executive Summary
Market Entry
Current Market Trends
Best Prospects
Market Size
Main Competitors
Current Demand
Registration Process
Barriers
Procurement and Tenders
Government and Association Links
FAQs
U.S. Commercial Service Contact Information
Tab Options
Executive Summary
Market Entry
Current Market Trends
Best Prospects
Market Size
Main Competitors
Current Demand
Registration Process
Barriers
Procurement and Tenders
Government and Association Links
FAQs
U.S. Commercial Service Contact Information
Executive Summary
The Mexican healthcare sector represents an important market for all types of products and services, though as of mid-2019 the public sector side of the market was undergoing a broad series of changes in the procurement system and structure of distribution with unclear ultimate outcomes. Overall, the import market for medical devices and supplies reached US $5.7 billion in 2019, and the pharmaceutical import market was US $4.6 billion in 2018. Neither of these estimates includes the import value of healthcare services. Currently, however, the entire sector is facing some challenges.
Mexico’s healthcare sector consists of three different sub-sectors: medical devices and supplies, healthcare services, and pharmaceuticals/bio-pharma. In 2018, medical devices were identified as a top-prospect sub-sector. Demand for imported medical devices were increasing, and there were not significant barriers to introducing new products into the market. Similarly, the services and pharmaceutical sub-sectors represented markets with a large U.S. presence. This year, with changes announced or envisioned by the new López Obrador administration, suppliers for all health sector products and services are grappling with significant changes in the procurement process, heightened receptivity to generics and low-cost providers, uncertain product approval and registration timings, and continued issues in intellectual property protection. We strongly recommend any new entrants into the market contact the US Commercial Service in Mexico (CS Mexico) for updated guidance.
Mexico operates a universal healthcare system that evolved through Federal Government actions in the mid-2000s and was fully enacted in 2012. The system is split between an extensive government-run healthcare network and private sector providers and insurers. The government network covers both the provision of care and pharmaceuticals. As of June 2019, the government-run system is further divided between multiple public healthcare networks. One is a network for government employees and their families called the Institute of Social Security and Services for Public Employees (Instituto de Seguridad Social de Trabajadores del Estado, or ISSSTE) covering some 13 million people. The Mexican Institute of Social Security (Instituto Mexicano de Seguridad Social, or IMSS) covers the rest of the employed population and their families, roughly 6 million people. A system called Seguro Popular provides basic health insurance coverage for the remainder of the informally employed or unemployed population. Individual Mexican states also provide independent healthcare services and the Mexican Armed Forces have their own independent healthcare system.
Healthcare partnerships also drive cross-border healthcare, including hospital affiliations with educational institutions, partnerships for specialized care, and franchise or network activity.
Healthcare Policy Issues
The López Obrador administration seeks to combine the three federal level systems into a single national system for all families, regardless of employment status, and has pushed forward staffing reductions through the public health system. At the same time, the President has made significant changes to the procurement system in an effort to reduce alleged widespread corruption and to force reductions in the cost of drugs, devices, supplies, and services. Under the prior administration, Mexico dedicated 4.2 percent of its GDP to the health care sector. Due to the changes proposed by the current administration, the budget for the medical sector is uncertain.
The Federal Commission for Protection against Health Risks, COFEPRIS, regulates health products in Mexico, and was recognized by the World Health Organization (“WHO”) as a National Regulatory Authority of Regional Reference (“NRARR”) following a positive evaluation of the agency’s performance. COFEPRIS has striven to improve the regulatory environment in Mexico to support faster market access for innovative medical devices. Streamlined processes are advantageous for patients, who benefit from increasing market competition and greater access to innovative technologies. The Mexican government estimates that nearly one million people use the public healthcare system each day, highlighting the significance of regulatory development in both public and private systems. By reducing bureaucracy and increasing transparency, COFEPRIS is seeking to improve the regulatory environment, which should enhance access to the second largest medical device market in Latin America.
U.S. exporters of medical technologies have an additional avenue for seeking COFEPRIS approval called the equivalency review process. If a medical device has been U.S. Food and Drug Administration (“FDA”) cleared, it may qualify for an equivalency review, which requires the exporters to submit less detail and paperwork than the standard review
Market Entry
All medical equipment and devices can be imported duty free with a NAFTA certificate of origin. Imports are subject to a 16 percent value added tax (VAT) over the invoice value.
All medical and healthcare products that touch or affect the human body need to be registered with the Mexican Secretariat of Health (SSA) prior to sale or use in Mexico. Foreign manufacturers of medical devices need to have a legally appointed distributor/representative in Mexico who will be in charge of obtaining the sanitary registration/market approval and will be responsible for the product(s) in Mexico. U.S. Commercial Service Mexico can provide a detailed list of requirements and advice for processing market approval in Mexico for U.S. medical devices.
Current Market Trends
As noted above, the López Obrador administration is reorganizing the public healthcare sector in a bid to improve nationwide access to healthcare services and medicines. In addition to the proposed consolidation of all public providers, there are some specific administrative changes already underway as of June 2019. Please see Mexico’s Country Commercial Guide for additional details.
The growth of medical tourism is also significant in Mexico. While estimates vary, Patients Beyond Borders estimates that 200,000 to 1.1 million patients travel to Mexico yearly. Most are Hispanics living in the United States, but others are U.S. citizens seeking lower-cost healthcare options, and a smaller group of individuals from Canada and the United Kingdom seeking fast treatment options combined with a tourism destination.
In recent years, most large public and private hospitals have tried to acquire modern and specialized medical devices. Some medium and small private hospitals with limited budgets buy used or refurbished equipment. Public hospitals, by law, cannot buy such products. To save resources, under the prior administration, many public and private hospitals hired companies to offer “integrated surgery services” and provide service “per event,” with all the necessary products required to perform a surgery. This concept was expanded to various processes such as sterilization, hemodialysis, and radiation treatment. In this way, hospitals could avoid making large investments in materials, pharmaceuticals, and instruments. This approach also reduced the costs involved in keeping and controlling inventories and maintaining instruments for specialized surgeries. Under the López Obrador administration, it is unclear how these policies may change in the public healthcare system.
All private healthcare facilities select suppliers by requesting price quotations. Their decisions are based on the best equipment at the best price.
Best Prospects
Diagnostic equipment
Respiratory care equipment
Patient monitors
Market Size
Healthcare spending (including investment) 2018
… as percent of GDP
5.5%
Hospitals, Procedures, Healthcare Professionals
Number of Hospitals 2018
4,346
…Public
1,386
…Private
2,960
Number of Hospital Beds 2017
181,000
Number of Surgical Procedures 2017
1,863,964
Physicians 2017
310,000
Demographics
Population 2018
126 million
Life expectancy men/women
73.5/79.2
Infant mortality
11.3 per every 1,000 under 5 years old
Percent of population older than 65 in 2018
70.26%
… projection, 2030
14.8% older than 60 years
Annual deaths 2018
680,400
… caused by heart disease
24.7 %
… caused by diabetes
17.4%
Prevalence - A range of non-communicable diseases have high rates of incidence, particularly obesity, heart disease, diabetes, and chronic respiratory diseases.
Sources: World Bank, Organization for Economic Co-operation and Development, World Health Organization, the Central Intelligence Agency World Factbook, the United Nations and Mexican Secretariat of Health .
Main Competitors
Most large international corporations offering medical devices have a presence in Mexico. Medium and small foreign suppliers usually sell through legally appointed distributors.
Mexico has also increased the domestic manufacturing levels of a variety of medical devices, mainly from international corporations that have established in-bond plants in Mexican border regions and other sites in the country. This resulted in Mexico increasing exports of medical devices by 13.7%, from US $11.6 billion in 2017 to US $13.2 billion in 2018. Most of this production and exportation is of simple products, but manufacturing of sophisticated medical devices such as pacemakers and cardiac valves is emerging.
The main third country suppliers of medical devices are Brazil, Canada, China, France, Germany, Israel, Italy, Japan, the Netherlands, South Korea, and the United Kingdom. A growing competitive problem for U.S. suppliers is low-cost and frequently lower-quality supply from Asian sources, particularly China.
However, medical products from the U.S. are highly regarded in Mexico due to high quality, after-sales service, and pricing, compared to competing products of similar quality. Consequently, U.S. medical equipment and instruments have a competitive advantage and are in high demand in Mexico.
Current Demand
In all, public healthcare institutions account for 70–80% of all medical services provided nationwide, while private healthcare institutions serve approximately 25–30% of the Mexican population, which includes the overlaps between the two systems and includes the 32 million people with private medical and accident insurance. In 2014 (most recent data available), Mexico had 22,831 public health care units, including 1,386 hospitals, of which 194 were highly specialized medical centers. In addition, there were 2,960 accredited private hospitals. Only about 100 private hospitals had more than 50 beds and the capacity to offer highly specialized services. Major private health provider groups include Grupo Empresarial Angeles, Star Medica, Hospital San Jose, Centro Medico ABC, Hospital Español, Amerimed Hospitales, Hospitales San Angel Inn, Grupo Christus Muguerza, and Medica Sur.
Imports supply about 80% of medical equipment and instruments and about 40% of medical disposable and dental products. In 2018, total imports in these four groups of products reached US $5.7 billion. Of these imports 68.4%, or US $3.9 billion, were of U.S. origin.
Registration Process
In terms of regulatory approvals and market access, Mexico remains sovereign as to setting and maintaining its regulations. For anything applied to or entering the body—whether a device, instrument, or pharmaceutical—a sanitary registration is mandatory.
Under the prior administration, Mexico had a fast-track process for the sanitary approval of U.S. FDA-approved medical devices and pharmaceuticals, which helped expedite imports from the U.S. For the market authorization of other products, the Mexican sanitary agency Federal Commission for the Protection against Sanitary Risk (COFEPRIS) made considerable advances in clarifying requirements and approval timelines through 2018. It is unclear how the registration process may change under the López Obrador administration.
Barriers
Besides the sanitary registration, the Mexican regulatory framework for the medical and pharmaceutical sectors includes norms and registration requirements. Compliance with Mexican Official Standards (Normas Oficiales Mexicanas or NOMs) is mandatory for all products sold in the Mexican territory. In addition to complying with the Official Standards, medical devices as well as pharmaceutical products such as active ingredients, finished medicines in bulk, and finished medicines in retail packages, must be registered with COFEPRIS.
Once the product has obtained a sanitary registration code, the importer must file an import permit application with COFEPRIS to have access to the Mexican territory. This process also applies to import of products for personal use or research that are exempted from sanitary registration. Products qualifying as North American under NAFTA must use the NAFTA Certificate of Origin to receive NAFTA beneficial treatment. Please see Mexico’s Country Commercial Guide for more information.
Some companies have experienced significant delays in receiving registration/marketing approvals from COFEPRIS, and this is compounded by the current uncertainty over COFEPRIS’ staffing and future role. In addition, foreign medical device manufacturers require a legally appointed distributor or representative in Mexico, responsible for the product and its registration process. It is highly recommended that U.S. companies ensure that they carefully submit all documents the first time and exactly as requested to COFEPRIS, as small errors or omissions have resulted in long delays in some cases. When in doubt, contact CS Mexico for updates on the market.
Challenges remain for many U.S. companies in achieving formulary listings for the many health coverage providers in Mexico. There are also limitations on U.S. companies competing with domestic manufacturers in public hospital tenders, thus giving preference to domestic Mexican products.
Procurement & Tenders
The Mexican federal government uses an online procurement information management tool called CompraNet (https://compranet.funcionpublica.gob.mx/web/login.html), similar to the United States FedBizOpps system. CompraNet is a repository for all official tender information and documents by all bidders. The current presidential administration is working to centralize all purchases in the Secretariat of the Treasury. This process is still evolving. Please review the Mexico’s Country Commercial Guide and contact Commercial Service Mexico for updated information.
Government and Association Links
Public Institutions
Private Hospital Chains
Industry Organizations
FAQs
1. What additional market research is available?
Mexico Country Commercial Guide 2019
Sanitary Registration U.S. Medical Devices 2017, November 2017
Health IT Market Overview, March 2012
Labeling for Medical Devices, February 2010
2. Which medical devices need to be registered with the Secretariat of Health (SSA)?
Medical equipment: Apparatus, accessories and instruments for a specific use dedicated to providing medical or surgical attention, or for use in patient examination, diagnosis, treatment and rehabilitation, as well as those used for conducting biomedical research activities.
Prosthesis, orthosis and functional aids: Devices intended for replacing or supplementing a human body function, organ or tissue.
Diagnostic agents: All supplies including antigens, antibodies, calibrators, controls or verifiers, reagents, reagent kits, culture media, contrast media and any other substance that is used as ancillary of other clinical or paraclinical procedures.
Dental supplies: Any substance or material used in providing dental health attention.
Surgical materials and medical supplies: Any device or material that, regardless of being supplemented with antiseptics or germicide agents, is used in the surgical practice or in the treatment of skin injuries, or other health care procedures.
Hygiene products: Materials and substances that are applied onto the skin or body cavities which have pharmacological or preventive action.
3. May I register my product directly with COFEPRIS?
U.S. Commercial Service Contact Information
Name: Juan Carlos Ruiz Juancarlos.ruiz@trade.gov
Name: Alicia Herrera Alicia.herrera@trade.gov
