Executive Summary
Market Entry
Current Market Trends
Market Size
Main Competitors
Current Demand
Registration Process
Reimbursement
Barriers
Procurement & Tenders
Trade Events
Government & Association Links
FAQs
U.S. Commercial Service Contact Information
Tab Options
Executive Summary
Market Entry
Current Market Trends
Market Size
Main Competitors
Current Demand
Registration Process
Reimbursement
Barriers
Procurement & Tenders
Trade Events
Government & Association Links
FAQs
U.S. Commercial Service Contact Information
Executive Summary
Healthcare expenditures in Argentina traditionally account for approximately 9 to 10% of GDP, among the highest in the region. Imports in the medical equipment and device sector have been estimated to account for around 70 to 75% of the total market, with local manufacturing of medical devices representing the remainder. The United States traditionally holds approximately a 20 to 25% market share, particularly in higher-end technology products.
Argentina’s healthcare system is comprised of four subsectors: public hospitals, the Social Security/union-run health insurance system, private medical insurance (prepagas ), and PAMI (similar to Medicare in the United States).
For public hospitals, the provinces and municipalities are responsible for financing and delivering healthcare. Each province has its own Ministry of Health managing healthcare delivery.
Around 35% of the population relies on public hospitals. The rest have some form of healthcare coverage, either from social security/union-run (60% of the population) or the private healthcare system (13%). Almost 10% of the population have more than one coverage system. Around 3.5 million elderly people and individuals with disabilities are covered by PAMI.
Argentina remains a key market for U.S. exports to Latin America. The United States is one of Argentina’s top three trade partners, and historically ranks among the top three source countries of foreign direct investment.
Market Entry
Imports of medical products must be performed by an importer registered with ANMAT as a frequent importer of medical equipment. Imported products generally appear under the name of the local registered importer who will fulfill the registration process as a representative of the U.S. company.
The Mercosur Common External Tariff (AEC in Spanish) applies to imports from countries outside the Mercosur area (Argentina, Brazil, Uruguay, and Paraguay). The AEC currently averages 14% for medical devices and 16% for inputs, with an additional 3% charged as fees in Argentina.
However, under the Sanitary Emergency Status (in force until December 31, 2022, and expected to be extended into 2023), the Government of Argentina (GoA) provided exemption of import duties for products related to combatting the pandemic, including in-vitro diagnostic reagents to detect COVID-19, surgical face masks, pulse oximeters, and oxygen concentrators, among other items. The GoA also has the authority to make direct purchases of supplies, equipment, devices, pharmaceutical products, other inputs for medical use as well as services related to coping with the pandemic.
Current Market Trends The Argentine medical device market is dominated by imports, which represent about 70 to 75% of the total market. The import market amounted to approximately $555 million USD in 2021 and is projected to reach about $603 million USD in 2022.
Imports grew strongly in the first months of 2022 (by over 35%) due to a surge in trade after the drop in imports experienced in 2020 and early 2021 during the strict lockdown. However, while imports are expected to continue recovering throughout 2022, they may do so at a slower pace, given macroeconomic concerns such as high inflation affecting purchasing power and price distortions due to a devaluated currency.
Most imports are concentrated in equipment and devices, consumables, patient aids including respiratory apparatuses, orthopedic implants, and dental products.
The United States was the second leading supplier of imported medical products in 2020, with an approximate import market share of 20%, second to China, which has become the market leader with approximately 22%, particularly in consumables. Other notable market suppliers are Germany, Mexico, Japan, Italy, and Brazil.
However, imports from the United States continue to lead in technologically advanced segments, such as orthopedics and prosthetics, implants and high-end disposables and consumables (specialized catheters, suturing materials, etc.).
Note: Import statistic publications by Argentine Customs were discontinued in early 2017. Source: Flitch Solutions.
Market Size
Healthcare spending (including investment)
… as percent of GDP
9.6% (2018) *
Number of hospitals
3391 (2020) **
Number of hospital beds
166,943 approx.(2020) **
Physicians (per 1,000 people)
4.1 (2020) **
Demographics
Population
47.3 million (2022)
Life expectancy men/women
73.2/80 (2019)*
Infant mortality (per 1,000 ba)
9.2% (2019) *
Percent of population older than 65
11% (2019) *
Annual deaths
340,400 .(2019)_*
…caused by [highest disease burden]
Cardiovascular Diseases (2019)
…caused by [second highest]
Cancer (2019)
Prevalence of [fastest growing disease burden]
Cancer (2019)
Sources: * PAHO; ** SISA/Argentine Ministry of Health
Main Competitors
Around 2,000 companies sell medical products and equipment in Argentina, with 275 companies being manufacturers of medical devices and the rest comprised of subsidiaries of international companies, importers, wholesalers, or retailers. Brazil poses strong competition since its imports enjoy a 0% tariff under the Mercosur trade agreement. Equipment made in the U.S., Japan, and Europe is known for its high level of technology and precision, whereas Argentine equipment, although durable, is generally low-tech.
Domestic production has been growing, although in general it is limited mainly to lower or middle-range equipment and supplies such as x-ray devices, peripheral equipment, illumination systems, furniture, operating tables, echographs and ECGs, monitors, oximeters, cobalt pumps, incubators, anesthesia equipment, sterilization equipment, basic lab equipment, instruments for arthroscopy, fixation instruments, instruments for video endoscopy surgery, wheelchairs, scales, etc.
Current Demand
Demand is determined by several factors, including public and private sector budgets, financing availability, socioeconomic conditions of the population, advances in technology, and the macroeconomic environment, among others.
The GoA, through the Universal Healthcare Coverage (CUS) program, emphasizes efficient spending, accessibility, and modernization. International financing has been invested in the implementation of universal health coverage, including the expansion of health insurance and primary and maternal care, and the required digital transformation under the Federal Digital Health Program, destined to facilitate healthcare access and efficiency through tools such as e-health records and telemedicine.
The pandemic focused procurement on certain urgently needed products during 2020 and 2021. This has now subsided, and demand has reoriented to products in areas that had been postponed during previous years, such as surgery, diagnostic imaging, and orthopedics, among others.
Simpler technology is more easily financed and thus considered mass-market. In this competitive market, the demand for these products is largely met.
Opportunities for U.S. exports include middle and high-end technology products, such as electro-diagnostic equipment and other specialized medical equipment and devices that do not compete with locally manufactured ones. There may also be potential in the market for implants, stents, cardiac valves, pacemakers, specialized catheters and cannulas, MRI equipment, echographs with Doppler analysis, hearing aids, and other specialized disposables.
However, based on the macroeconomic concerns mentioned before, many medical companies are reducing costs and evaluating representation and purchase opportunities on a case-by-case basis.
Registration Process
ANMAT, the local equivalent to the United States’ FDA, is the Argentine agency responsible for regulating the registration of medical products, biological products, dental hygiene products, healthcare sanitation and disinfectants, personal hygiene, cosmetics and perfumes, foods and dietary supplements, and medicines.
Imported medical products need to be registered with ANMAT through an authorized medical importer, and it is important that the medical device has prior approval by the FDA.
Exporters must appoint a local medical importer, or representative company, which will submit the product registration application as the Registration Holder and will be the point of contact with ANMAT.
It is important to note that even if a product is registered in another Mercosur country, its registration will not be considered valid unless it is registered with ANMAT in Argentina.
Products may be classified under the following categories: Class I, II, III, or IV, according to the risk level they present, from simpler to more complex technology. Documentation required may vary according to the product and can also depend on what the ANMAT evaluator requires for each case. In general, the following documents are required:
Apostilled FDA Certificate (Certificate to Foreign Government)
Apostilled letter or Certificate of Representation/Distribution in Spanish
User or Technical manual in Spanish
Essential Requirements (ER) Matrix
Brochures and labels
The product registration process may take from 6 to 12 months. Recent faster Class I and Class II approvals have been implemented by ANMAT, with certain requirements.
Additional documents may be required, such as electrical safety certifications, manufacturing flowchart processes and descriptions, sterilization methods and parameters, or scientific or clinical evidence reports. Further description of regulations on medical products can be found at ANMAT .
Reimbursement
The Compulsory Medical Program (PMO - Programa Médico Obligatorio ) establishes the basic health services that the social insurance (obras sociales ) and private insurance (medicina prepaga ) sectors must guarantee under Law No. 23,660. PMO coverage is the minimum service or medicinal coverage mandated by law. Reimbursement percentages and amounts are dependent on whether a medical practice is included in the PMO list. Values or practices that exceed those established in the PMO list are considered optional and covered either by premium healthcare plans or by patients’ out-of-pocket payments. The principal concerns with PMO are that the values are not updated regularly, and most advanced practices are not included within its structure. The PMO was established and is maintained by the Ministry of Health Resolution 201/02.
Barriers
Argentina utilizes an Overall System for Import Control (Sistema Integral de Monitoreo de Importaciones, SIMI) which comprises automatic import licenses (ALs) and non-automatic import licenses (NALs). Some sensitive products require previous approval through NALs. Please check with us on which is required for your product.
Procurement & Tenders
To participate in federal government procurement tenders, companies need to be registered with the National Public Administration Contracting System, with a few exceptions. The national public procurement portal https://comprar.gob.ar/ publishes and manages the electronic procurement processes of goods and services. Provinces conduct their own procurement processes and most provincial governments have their own portals which list their specific procurement information.
Preference is given to domestic goods under a Buy Local regime. The Unión Argentina de Proveedores del Estado (UAPE) is a prominent NGO looking out for the interests of companies participating in national, provincial, and municipal procurement. UAPE has a database on government procurement.
Trade Events
ExpoMEDICAL www.expomedical.com.ar
Government Links
Argentine Ministry of Health: www.msal.gov.ar
ANMAT – Argentine Medical Technology Food and Drug Administration: www.anmat.gov.ar
AFIP - Argentine Tax and Customs Agency: www.afip.gov.ar
CADIEM - Argentine Chamber of Medical Inputs, Implants and Devices: www.cadiem.org.ar
CIRA - Argentine Association of Importers: www.cira.org.ar
FAQs
1. Is the FDA approval or CE mark enough to export a medical device to Argentina?http://www.anmat.gov.ar/ProductosMedicos/tramites/productos.asp
2. Who can register the product and be the registration holder in Argentina?
4. If the medical product is registered in another Mercosur country, is the registration valid for Argentina?
U.S. Commercial Service Contact Information
Name: Liliana PazLiliana.Paz@trade.gov
