Healthcare Resource Guide: Argentina

Last Updated: October 2019

 

Argentina Statistics



Summary

Market Entry

Current Market Trends

Main Competitors

Current Demand

Registration Process

Reimbursement

Barriers

Procurement & Tenders

Trade Events

Government Links

Best Prospects

Statistics Snapshot

CS Contacts

 

Capital: Buenos Aires

Population: 45 Million

GDP: $518 billion

Currency: Peso (ARS)

Language: Spanish

Summary

Healthcare expenditures in Argentina account for approximately 9% of the GDP, among the highest in the region.

Imports in the medical equipment and device sector have been estimated to account for around 70-75% of the total market, with local manufacturing of medical devices representing about 25% of the market. The United States continues to lead the Argentine import market of medical products and equipment, and currently holds approximately a 25% market share, particularly in higher-end technology products.

Argentina’s healthcare system is comprised of 4 subsectors: Public Hospitals, the Social Security/Union-run Health Insurance System, Private Medical Insurance (Prepagas), and PAMI (similar to Medicare in the United States).

The authority responsible for the approval of medical products, medicines, and foods is ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) - the Argentine equivalent to the U.S. Food and Drug Administration (FDA).

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 the public hospital subsector. The rest have some form of healthcare coverage, either from social security/union-run (50% of the population) or the private healthcare system (10%). 3.5 million elderly people and individuals with disabilities are covered by PAMI.

Regarding the healthcare market in general, the Government of Argentina, through the Universal Healthcare Coverage (CUS), emphasizes efficient spending, accessibility, and modernization.

Argentina remains a key market for U.S. exports to Latin America. The United States is one of Argentina’s top three major trading 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 (CET) applies to imports from countries outside the MERCOSUR area (Argentina, Brazil, Uruguay, and Paraguay). The CET currently averages 11% for medical devices and 13% for inputs, with an additional 2.5% in statistics fees. (Note: the statistics fee went up to 2.5% temporarily, until the end of 2019.)

Current Market Trends

The Argentine medical equipment and device market is dominated by imports. The total import market amounted to approximately US $840 million in 2017 (latest data available). Imports have grown almost steadily (despite a few years of negative growth) representing 70% of the total market in 2010 and reaching 82% in 2017. Argentine exports of medical products amounted to US $57 million in 2017, in a decreasing trend. Imports are expected to continue growing at a modest rate of 1% in 2019-2020.

The United States continues to be the leading supplier of imported medical products, with an approximate import market share of 25% followed by China, Germany, Mexico, and Japan.

Most imports are concentrated on equipment (50%), followed by implants (29%) and inputs. Imports from the U.S. continue to lead in these technologically advanced segments.

Statistics were based on following Mercosur HS Codes: 90.18.1; 90.18.20; 90.18.3; 90.18.4; 90.18.50; 90.18.90; 90.19.20; 90.21; 90.22.10; 90.22.2; 90.22.30.00; 90.22.90; 90.27.90.99.100.N; 90.27.90.99.200.U.; 30.06.10; 39.2690; 40.1511; Note: Import statistic publications by Argentine Customs were discontinued in early 2017. Source: CADIEM.

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: public and private budget and expense, socioeconomic conditions of the population, and advances in technology. Medical products and technology developed and produced in the United States are highly regarded in Argentina. This is particularly relevant when U.S. exporters can offer high quality products at competitive prices. For any medical products or equipment that cannot be manufactured locally, export opportunities continue to exist for U.S. companies.

Opportunities for U.S. exports in this sector 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.

Simpler technology is more easily financed and thus considered mass-market. In this competitive market, the demand for these products is largely met. In any situation, product potential should be determined on a case-by-case basis.

Registration Process

ANMAT, the local equivalent to the US 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.

Regulatory consultants cannot register a medical device. 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. Documentation required may vary according to product and can also depend on what the ANMAT evaluator requires on 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; 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 are considered optional and covered either by premium healthcare plans or by patients’ out of pocket payments. Principal concerns with PMO are that 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. http://www.sssalud.gov.ar/pmo/res_s_02_201.pdf.

Barriers

The previous and more complex DJAI system (Sworn Advanced Affidavit of Imports system) has been replaced by an Overall System for Import Control (Sistema Integral de Monitoreo de Importaciones – SIMI, through Resolution AFIP 3823/2015). The new system comprises Automatic (AILs) and Non-Automatic Import Licenses (NAILs). Some sensitive products still require previous approval through non-automatic import licenses. Of the previous 19,000 categories of products that needed DJAI import permits, approximately 18,000 will now be granted automatic entry, and approximately 1,400 will have non-automatic licenses.

This Resolution is supplemented by Resolution Nº 5/2015 through the Ministry of Production, which provides details on AILs and NAILs, the information required from importers, and products that require NAILs (Annexes II through XVII). Under the SIMI, importers will need to present the information requested through the Argentine Tax and Customs - AFIP. The declaration of imports will have a valid term of 180 days upon approval.

The importation of used and refurbished medical equipment is either forbidden or highly restricted. It is generally not recommended for U.S. exporters and distributors.

Procurement & Tenders

In order to participate in federal government procurement tenders, companies need to be registered locally with official representatives in the country. Most provincial governments have their own websites with specific procurement information. A prominent NGO looking out for the interests of companies participating in national, provincial, and municipal procurement is the Unión Argentina de Proveedores del Estado (UAPE). UAPE has a database for government procurement.

Trade Events

Expomedical – September 25-27, 2019

International Show for Products, Equipment and Services for the Healthcare Sector

http://www.expomedical.com.ar/

Expofarmacia - May 2020

Pharmaceuticals Trade Fair

https://expofarma.org.mx/

Government Links

Argentine Ministry of Health - http://www.msal.gov.ar/

ANMAT – Argentine Medical Technology Food and Drug Administration – http://www.anmat.gov.ar/

AFIP - Argentine Tax and Customs Agency – http://www.afip.gov.ar/

Association Links

CADIEM - Argentine Chamber of Medical Inputs, Implants and Devices http://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?

No. In order to export a medical device to Argentina, the device needs to be registered with ANMAT (see info above). However, it is important that the medical device has prior approval by the FDA. Further information can be accessed at http://www.anmat.gov.ar/ProductosMedicos/tramites/productos.asp

2. Who can register the product and be the registration holder in Argentina?

Exporters must appoint a local medical importer (representative) company which will submit the product registration application as the Registration Holder and will be the point of contact with ANMAT. The importer/representative must be duly registered and authorized by ANMAT (with approved building infrastructure, warehouse and corresponding areas, and a technical director, among other requirements). There could be more than one registration holder.

3. Can the medical device registration application be submitted by regulatory consultants?

No. See above (item 2)

4. If the medical product is registered in another Mercosur country, is the registration valid for Argentina?

No. The medical product needs to be registered with ANMAT.

Best Prospects

  • Electrodiagnostic equipment
  • Ultrasound equipment, and other medical devices
  • Implants, stents, cardiac valves, pacemakers
  • Specialized disposables

Statistics Snapshot

Market Size

Healthcare spending (including investment)

US$605,188 (2014)

... as percent of GDP

7%

Hospitals, Procedures, Healthcare Professionals

Number of hospitals

5,178 approx.

Number of hospital beds (per 1,000 people)

4.7

Number of surgical procedures

2,375,750 approx.

Physicians (per 1,000 people)

3.859

...of which surgeons (per 100,000 population)

10.47

Demographics

Population

45 million

Life expectancy men/women

74/80.4

Infant mortality

0.01%

Percent of population older than 65

11.46%

...projection, 2030

12.89%

Annual deaths

337,928 approx.

...caused by [highest disease burden]

Cardiovascular Diseases

...caused by [second highest]

Cancer

Prevalence of [fastest growing disease burden]

Cancer

U.S. Commercial Service Contact Information

Name: Liliana Paz

Position: Senior Commercial Specialist

Email: Liliana.Paz@trade.gov

Phone: +54-11-5777-4519


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