Overview

Uruguay maintains a highly inclusive and structured healthcare system that integrates both public and private providers under the framework of the National Integrated Health System (Sistema Nacional Integrado de Salud, or SNIS). Since its creation in 2007, SNIS has guaranteed universal coverage for the population with financing administered through the National Health Fund (FONASA). Those who contribute to FONASA have the option to choose a private or public healthcare provider. Most opt for one of the over 40 private Mutualista plans, which function as membership plans to private hospitals, without deductibles or lifetime caps. Additionally, there is a small percentage of the population who additionally pay private insurance to have access to premium services and hospitals.  

The healthcare sector invests heavily in technology and modernization and accounts for roughly 9 percent of Uruguay’s GDP with projections anticipating a rise to approximately 10 percent by 2027. The development of Uruguay’s digital health ecosystem has been a defining feature of its healthcare modernization strategy. In 2012, the government launched Salud.uy to create a nationally integrated and interoperable digital health system. Progress accelerated in 2017 with the approval of Decree 242/017, which established the National Electronic Health Record platform, or HCEN. This initiative required that all healthcare providers register their patients by 2020 and ensure that at least 90 percent of the healthcare interactions were recorded electronically. 

Building on this digital infrastructure, Uruguay introduced a nationwide digital prescription system in 2019, allowing patients to access and fill prescriptions online, sometimes with the added convenience of home delivery. The same year saw the creation of a National Network of Diagnostic Imaging, through which healthcare professionals across the country could securely access patients’ imaging results from any connected device. In March 2020, Uruguay enacted its first comprehensive telemedicine law, laying the regulatory groundwork for the expansion of remote healthcare services and standardizing the provision of care through digital means.

Uruguay’s doctor/population ratio stands at second place in Latin America and eleventh in the world, with 4.6 doctors/1000 people according to the World Bank’s latest information. However, the small population does not allow doctors to be exposed to a diversity of clinical cases and specialize in complex or rare pathologies. Therefore, opportunities exist for specialized training and for second-medical opinion services. 

All diagnostic reagents, therapeutic devices, and medical equipment must be registered with the Ministry of Public Health.  This process is typically undertaken by a local representative as it must be initiated by a local company that is pre-registered at the Ministry.  It is important to note that having FDA approval alone is not sufficient for product registration. Additional documentation, including a letter from the manufacturer designating the local company as the authorized representative/distributor, is required. The registration process is often complex and time-consuming. Once obtained, the record belongs to the company that initiated the request. If multiple-authorized distributors operate in the market, each one must register the product at the Ministry.  

The registration is valid for five years and can be renewed upon paying a fee. Procurement by the public sector follows a competitive tendering process. All offers are published online at the state’s procurement agency platform called “SICE” but bidders must already be registered at “RUPE” registry as a supplier to the Uruguayan government. Especially in the healthcare sector, tenders may require local technical service and physical presence in Uruguay, thus partnering with a local company is sometimes necessary, and in general, highly advised. Any product that requires operator training or needs after-sales technical service, such as medical equipment, should have a qualified local company ready to assist the customer. After-sales technical service is mandatory in most public tenders. Company representatives who respond from neighboring countries tend to be less satisfying to Uruguayan customers.

Healthcare Export Opportunities to Uruguay:

Leading Sub-Sectors

Pharmaceutical

Source: SP CONNECT- Global Trade
Analytics Suite – USD million
HTSUS: 2936, 2937, 2939, 2941, 3001, 3002, 3003, 3004, 3005, 3006 (pharmaceutical products).                
Exchange rate: (Simple average [(Value at January 1+Value at December 31)/2])
Source: BEVSA

Between 2022 and 2023, Uruguay’s total pharmaceutical exports declined by 8.4 percent, but rebounded in 2024 with a 13.7 percent increase. Imports rose steadily, growing by 4.2 percent in 2023 and 11.8 percent in 2024. Imports from the United States followed a similar trend, with a sharp increase of 42.9 percent in 2023 and a further 25 percent in 2024.  Over the same period, the United States’ trade surplus with Uruguay grew significantly – by 53.9 percent in 2023 and 22.5 percent in 2024.

In 2024, the United States ranked as the third largest supplier of pharmaceuticals to Uruguay, accounting for 11.3 percent of imports and behind Argentina with 13.3 percent and Germany with 12.9 percent. Sixty-nine percent of pharmaceuticals imported from the United States were medicaments, followed by human and animal blood with 25 percent. Pharmaceuticals are the leading industry in the life science sector. Uruguay has a long history in pharmaceuticals and has over 30 pharmaceutical facilities. The workforce is highly skilled and knowledgeable, and the government has established a transparent regulatory framework in which companies and laboratories operate.  

International pharmaceutical companies have expressed concerns about Uruguay’s intellectual property (IP) regime, particularly regarding the lengthy process for granting patent protection, which can extend up to 10 years. This delay is especially problematic for pharmaceutical products developed outside of Uruguay. In December 2020, Uruguay enacted Article 325 of Law No. 19924, amending Article 99 of Patent Law No. 17164. This amendment stipulates that patent holders cannot claim compensation for infringements occurring between the publication and granting of a patent for pharmaceutical products, unless it is irrefutably proven that a substantial part of the product’s development occurred within Uruguay. This provision has raised concerns among international pharmaceutical producers, as it can take up to 10 years to be granted intellectual property protection rights for pharmaceuticals, with the average time between filing and granting of patents in Uruguay has been approximately 5.5 years and increasing. This prolonged process affects the timely protection of pharmaceutical innovations.  In response to these challenges, Uruguay approved its accession to the Patent Cooperation Treaty (PCT) in June 2024. This move aims to streamline the patent application process and align Uruguay’s IP system with international standards. However, the full implementation of the PCT and its impact on reducing patent granting times remain to be seen. 

According to Uruguay XXI, in 2023 Uruguay’s total exports from the health sector – including medical equipment and exports from free trade zones – amounted to $310 million by 40 companies, representing more than 2.7 percent of the country’s total exports. Pharmaceutical exports for human use totaled $179 million (more than half of which were exported from free trade zones). Exports of veterinary products reached $90 million, while medical equipment exports amounted to $42 million. Both products of human and veterinary use were predominantly sold to other Latin American countries, primarily Argentina.  Additionally, Uruguay’s pharmaceutical industry exports vaccines and serums that are primarily for veterinary use and packaged for retail sale. Pharmaceutical laboratories are dependent on imported raw materials, mainly from China, because Uruguay and other countries in the region do not produce these chemicals. 

Prior authorization by the Ministry of Public Health is needed for import, representation, production, and commercialization of medicines for human use. For veterinary products, prior authorization by the Ministry of Livestock, Agriculture, and Fishing is required.  Uruguay’s regulatory framework offers important advantages for logistics operations, with incentives for the installation of regional distribution centers to handle goods in transit (free trade zones, free port and airport, temporary admission, and deposits). In 2023, the transit of pharmaceutical products in Uruguay reached $857 million, which is more than twice the amount exported by the sector. This business model has grown over the last decade and has become an important option for companies serving the region. The transit of pharmaceuticals through Uruguay shows an important flow of goods from the northern hemisphere, 49 percent come from Europe, 18 percent from North America (mainly from United States), and 29 percent from Mercosur (mainly from Argentina). The final destinations are 51 percent to Mercosur, 24 percent rest of South America, 10 percent Central America, and 14 percent North America.

Medical Equipment

Source: SP CONNECT- Global Trade
Analytics Suite – USD million
HTSUS: 9011;9012;9018;9019;9021;9022;9027
Exchange rate: (Simple average [(Value at January 1+Value at December 31)/2])
Source: BEVSA
 

Between 2022 and 2023, Uruguay’s total Medical Equipment exports increased sharply by 46.4 percent, followed by a more moderate rise of 17.1 percent in 2024.  Imports also grew steadily, rising by 13.2 percent in 2023 and by 8.9 percent in 2024.  Imports from the United States mirrored this trend, with a 11.9 percent increase in 2023 and a further 6.4 percent in 2024.  Over the same period, the United States’ trade surplus with Uruguay narrowed slightly – by 4.3 percent in 2023 and 36.4 percent in 2024.

In 2024, the United States ranked as the largest supplier of medical equipment to Uruguay with 31.4 percent of the total imported. Main products imported from United States in this category were instruments and appliances used in medical, surgical, dental, and veterinary sciences (with 30.2 percent of the total), orthopedic appliances (with 29.2 percent of the total) and instruments and apparatus for physical or chemical analysis (with 21 percent of the total). Several companies have expressed frustration with Uruguay’s medical device registration process, citing the long period of time and high costs needed for registration, and several report opting to not bring their full suite of devices to Uruguay given the regulatory difficulties and limited market size.

Digital Health

The medical technology market in Uruguay is expected to continue growing driven by a combination of demographic trends – including an aging population and rising chronic disease burden – as well as expanding public investment in health infrastructure and technology upgrades. U.S. exporters of advanced diagnostic devices, imaging systems, and surgical equipment could find a receptive market, particularly when products align with national priorities around quality, interoperability, and efficiency.

Uruguay’s healthcare system is comprehensive and well-established but faces pressures related to rising costs, chronic disease prevalence, and aging demographics. The medical technology market in Uruguay is projected to reach $702.4 million in 2024, with strong demand for connected health services and medical diagnostics, according to Statista. U.S. companies with expertise in AI-based diagnostic tools, chronic disease management, and platforms enabling personalized and predictive medicine could find potential in Uruguay. 

Opportunities and challenges

Private hospitals in Uruguay are investing in technology and modernizing their facilities, creating opportunities for U.S. manufacturers in hospital equipment and technology. Some providers are exploring U.S. ExIm Bank products and services to facilitate financing for local healthcare institutions for the acquisition of U.S. products, services, and technologies. U.S. companies are most successful Uruguay when offering price-competitive, high-quality, and innovative products. 
Due to its geographical location, free trade zones, and legal and tax framework, Uruguay has positioned itself as a logistical hub. The free trade zones, free seaport, free airport, and warehouse regulations provide a complimentary framework for establishing distribution centers that supply medical goods to other locations in Latin America.  

U.S. companies seeking to enter Uruguay’s medical and pharmaceutical market should be aware of regulatory challenges related to product registration. The Ministry of Public Health (MSP) is responsible for authorizing the import, sale, and use of pharmaceuticals, medical devices, cosmetics, and nutritional products. Companies operating in this sector have reported significant delays in obtaining product approvals, in some cases exceeding 12 months. While the Uruguayan government has acknowledged these concerns and reports efforts to improve regulatory efficiency, including potential updates to legislation and increased staffing, U.S. firms should plan for extended timelines and factor regulatory costs into their market entry strategy.  Companies are encouraged to consult with local legal and regulatory experts to navigate the approval process effectively.