Executive Summary
Market Entry
Current Market Trends
Best Prospects
Market Size
Main Competitors
Current Demand
Registration Process
Reimbursement
Barriers
Procurement & Tenders
Government & 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
Reimbursement
Barriers
Procurement & Tenders
Government & Association Links
FAQs
U.S. Commercial Service Contact Information
Executive Summary
Uruguay imports almost all its medical equipment, as there is little local industry producing these products. Major market opportunities are for new, technologically advanced supplies and equipment.
The Uruguayan health sector includes both public and private sub-sectors. Uruguay’s expenditure in healthcare is approximately nine percent of GDP, with the public sector representing 71 percent of these expenditures. Health sector funding is complex, mixed between public and private sources. Multiple funding comes from central government funds, user contributions, and state transfers.
The authority responsible for implementing and enforcing health regulations in Uruguay is the Ministry of Public Health (MPH). In 2007, the government created an Integrated National System of Healthcare which oversees both the public and private sectors. Uruguay has a national policy on health technology that is part of the National Health Program. The National Health Technology Management Unit is the department which plans medical equipment allocation. This department must approve any incorporation of new technology, either for the public or private sector, considering the scientific information available, the need for its use, and the rationality of its location and functioning.
Private care is organized through Medical Care Institutions, private hospitals, partial health insurance, private clinics, and highly specialized medical institutions.
The demographics of Uruguay ensures that the demand for medical supplies and equipment is relatively steady and will continue to be so. Compared to other Latin American countries, Uruguay has an aging society. Fifteen percent of the population is 60 years of age and over, and the average life expectancy is 73 for males and 81 for females. The average age is 38 years.
Cardiovascular problems are the most common cause of death among the population over 45 years of age, with malignant tumors as a secondary cause. All medical devices related to these diseases will continue to be in great demand.
Market Entry
Most of international medical device and technology providers do not have subsidiaries in Uruguay and therefore work with local representatives or distributors.
Purchasing systems in the public sector use a competitive tendering process for the procurement of medical devices and diagnostics technologies. Most purchases are made through public hospital tenders, which are assigned to companies that are pre-selected for public tender opening bids, which makes having a qualified importer/distributor with access to the procurement decision makers important for U.S. companies. MPH can also import medical devices on its own, for specific purposes. https://www.gub.uy/ministerio-salud-publica/tramites-y-servicios/tramites . https://www.gub.uy/ministerio-salud-publica/comunicacion/publicaciones .
US companies wanting to export medical devices to Argentina, Brazil, or Chile should consider the benefits offered in Uruguay’s free trade zone regime. This regime provides tax exemptions and offers good conditions for those companies considering Uruguay as their regional hub. Uruguay has extensive experience in logistics and distribution to the region, and consequently has become an ideal hub for setting up Regional Distribution Centers (RDC). Distributing from Uruguay may present several benefits for the business, such as increasing logistical efficiency, reducing lead times and the possibility to adapt products to country requirements while the product is in transit. As an example, the pharmaceutical industry has had an exponential increase of storage and transits through Uruguay, reaching 680 million USD in 2018, which is three times the amount of Uruguayan exports of these products.
A typical price structure for imported medical device products from the United States is as follows. This is an example for cardiac stimulators or pacemakers (HS 902150.00.00):
CIF Value
1,000.00
USD
Import Tariff
10%
100.00
USD
Imaduni
4%
40.00
USD
Consular Tax
5%
50.00
USD
Extraordinary Tax
12.00
USD
T.S.A.
2.00
USD
Transit guide
3.58
USD
Electronic Cert.
5.12
USD
Airport
17.33
USD
Certificates
2.00
USD
Sub Total
232.03
USD
VAT (recoverable on sale)
148.20
USD
Income Tax
45.60
USD
Total Expenses
425.83
USD
Total Import Cost
1,425.83
USD
Current Market Trends
Due to the lack of national industry, the types of products imported are diverse. The amount of medical device imports has remained quite stable during the last five years (an average of US $74 million per year), with an increase last year up to $80 million. The United States has maintained its leadership as a supplier in the sector. Import of instruments, appliances, apparatus, and orthopedic appliances (HS 9018 and 9021) represent 80-90 percent of total medical imports.
Best Prospects
Medical Products: Opportunities for US exports in this sector include all technology and supplies products, as Uruguay does not have a significant local industry. The largest imports were in the following HS codes:
HS Position
Product
9018
Instruments and appliances used in medical, surgical, dental, or veterinary sciences, including scintigraphy apparatus, other electro-medical apparatus, and sight-testing instruments. Ultrasound equipment, magnetic resonance.
9019
Oxygen therapy, massage apparatus, respiratory therapy, and resuscitation.
9021
Orthopedic appliances, including crutches, surgical belts, and trusses; splints and other fracture appliances; artificial parts of body; hearing aids and other appliances, which are worn, carried, or implanted in the body
9022
Apparatus based on the use of X-rays or of alpha, beta, or gamma radiation, whether for medical, surgical, dental, or veterinary uses, including radiography or radiotherapy apparatus, X-ray tubes and other X-ray generators, high-tension generators, control panels and desks, screens, examination or treatment tables and chairs.
Pharmaceutical Products: Pharmaceutical laboratories in Uruguay are highly dependent on imported raw material as a result of the lack of a developed domestic market of basic chemicals. The low development of the basic chemical producer market is a reality that is seen throughout the region and leads to the main sources of raw materials being developed countries.
Clinical Lab Equipment: Clinical laboratory equipment and disposables are practically all imported. Clinical health investigation in Uruguay plays an important role in the Uruguayan economy due to specialized labor and equipment requirements.
Market Size
Healthcare spending (including investment)
… as percent of GDP
9.06 % of GDP (2016)
Hospitals, Procedures, Healthcare Professionals UN:
Number of hospitals
102 (2017)
… available beds per capita
12/10,000 population (2016)
Number of surgical procedures
6,394.00 (2012)
Physicians
3.74 physicians/10,000 population (2016)
Dentists
14.8/10,000 population (2017)
Demographics
Population
3.51 million (2018 est.)
Life expectancy men/women
total population: 77.8 years
male: 74.2 years
female: 81.1 years (2018 est.)
Infant mortality
total: 6.5 deaths/1,000 live births
Percent of population older than 65
14.8 (2018)
Annual deaths
32.6 deaths/1,000 population (2018 est.)
Main Competitors
The USA is the main supplier of medical devices in Uruguay, with 31% of the market share, followed by China (11%) and Germany (9%). Other important suppliers, but with less than 5% of the market share, are Switzerland, Costa Rica, Ireland, Argentina, Mexico, Japan, and Brazil.
U.S., Japanese, and European-made equipment is known for its high level of technology and precision. China is well positioned with low-priced medical supply offerings such as syringes, needles, among others.
In 2018, the USA was the strongest exporter of high technology products to Uruguay (HS Code 9022) and was the leader in the market with 49 % of imports for advanced technologies, such as X-ray apparatus and tomography equipment.
Current Demand
Uruguay imported 80 million dollars in medical equipment last year, 3% directly by the government and 97% by more than 400 companies from the private sector (including hospitals, laboratories, and clinics). These importing companies can then sell equipment to the government by participating in open tenders.
Registration Process
All products must be registered with the MPH. This registration may be done by manufacturers, representatives, distributors and/or importers of the products. For registration, companies must provide the following information and documentation:
Proof of the registration of the company and the authorization of its premises.
A copy of the documentation that is attached to the product at the time of its commercialization (brochures, instructions, guarantees, etc.).
Certificate of sales authorization issued by the accredited institution in the country of origin or quality certificate granted by an accredited body. In the case that the product does not have these certifications, it can be replaced by an affidavit of the company that registers the product ensuring quality and safety of it.
Technical documentation specific to the type of product to be registered.
Affidavit, certifying that the equipment is new or used. In the case of used equipment, it must be accompanied by the corresponding recycling protocol, carried out by a qualified and competent company.
Applications for registration must be signed by the person in charge of the Company and the Technical Director. Officials will determine from the documentation provided by the company whether they need samples or must carry out technical inspections to complete their study and will inform the company concerned. If an analysis is carried out, an official copy will be issued with details of the examinations made and the results obtained.
In general, the following documents are required for registering products:
Quality Certifications for the production part
Quality Certifications for the product
Certificate of Free Sale from the country of origin of the product
Technical report of the product
Affidavit of maintenance of the equipment during the product life
For used equipment: data about the recycling company and the recycling protocol
In urgent or emergency situations, supplier companies may import reagents, diagnostic reagents, medical equipment and/or therapeutic devices not yet registered, upon request of a competent professional in the matter and approved by the MPH. The application for registration must be made with a term of no more than 30 days. The signatory professional is jointly and severally liable for any deficiencies, until the registration of the device has been approved.
Details of the procedure and costs can be found online, at the following official website: https://www.gub.uy/tramites/registro-autorizacion-venta-uruguay-productos-medicos and questions can be submitted to:
Some relevant regulations include:
Decree 165/99
Decree 402/89 – Articles 12, 13 y 14
Decree 43/004
Reimbursement
There is no reimbursement process in Uruguay.
The National Integrated Health System regulates the right to health protection for all inhabitants of the country through a National Health Insurance (NHS) system, which is financed by the National Health Fund (FONASA). This system extends the medical coverage of workers to their family. Contributions are based on the employee’s salary and payment varies from 3 to 8%, depending on the family structure and the amount of their salary. The employer pays a 5% contribution. Under the National Integrated Health System, people can choose between public and private hospitals or a private insurance. A private insurance plan has an extra cost not covered by FONASA that is paid by the final user.
In some cases, private companies offer private insurance to their employees as a work benefit, where the employer pays a certain percentage of the annual fee to an insurance company and the other percentage is covered by FONASA. Private insurance allows Uruguayans to attend private hospitals and clinics.
Barriers
Uruguay has a favorable import climate. There are no known barriers to U.S. medical equipment, devices, pharmaceuticals, laboratory equipment, or diagnostic tests.
Although Uruguay is member of Mercosur and there is a common external tariff (CET) applicable to imports from countries outside Mercosur, Uruguay has its own tariffs on certain products, called exceptions to CET. These exceptions are applicable to medical devices and represent a reduction to the common external tariff and therefore to the importing costs on these products. Customs duties applicable to medical equipment in Uruguay range from zero to 16%.
Most products included in the HS codes 9018, 9019, 9021, and 9022 are charged with an extra tax of 2% on CIF Value (Cost, Insurance and Freight Incoterm) when used for medical purposes and 10% on CIF Value when associated with orthodontics. The entity that collects this special tax is the Pension Fund of University Graduates (Caja de Profesionales Universitarios del Uruguay), according to the Article 71 Law Nº 17.738.
Procurement & Tenders
Information on government contracts is available from the Agencia de Compras y Contrataciones del Estado (Government Procurement and Contracting Agency), Andes 1365 piso 8, 11100 Montevideo; telephone: +598-2604-5360; e-mail: compras@acce.gub.uy ; website: https://www.gub.uy/agencia-reguladora-compras-estatales/ (available only in Spanish).
The Centralized Purchasing Unit (UCA) within the Ministry of Economy and Finance is tasked with centralizing the purchasing of food and medicinal products for government bodies. The UCA may also engage in purchasing products for private persons in situations in which there are problems supplying the population (such as shortages and/or high prices).Invitations to Tender https://www.gub.uy/agencia-reguladora-compras-estatales/ .
Government & Association Links
Local Associations:
Government Links:
FAQs
1. Are FDA approval or other international certifications enough to export a medical device to Uruguay?
No. In order to export a medical device to Uruguay, the device needs to be registered with the Uruguay Ministry of Health. The registration can be done either by the manufacturer or the distributor. It takes around 12 months to get the registration done and it expires every five years. 2. What are the major sales channels in Uruguay? https://www.mercadolibre.com.uy/ . Distributors often have their own site in Mercado Libre and consumers feel confident purchasing from there.
U.S. Commercial Service Contact Information
Name: Alicia Machado Alicia.Machado@trade.gov
