Healthcare Resource Guide: Argentina

 

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: 44 Million

GDP: $545 billion

Currency: Peso (ARS)

Language: Spanish

Summary

Healthcare expenditures in Argentina have traditionally accounted for approximately 7% 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. The United States continues to lead the Argentine import market of medical products and equipment, and currently holds a 25% market share (2017), particularly in higher-end technology products.

The administration that took office in December 2015 took highly-needed measures to stimulate trade, such as eliminating import restrictions, removing limitations on dividend repatriation, and unifying the exchange rate. However, some critical issues still need to be addressed to attract more trade and investment.

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 (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica - the Argentine equivalent to the U.S. Food and Drug Administration), 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 14% for medical products with an additional 0.5% in statistics fees.

Current Market Trends

Unit: USD millions

 

2015

2016

2017 (estimated)

2018

(estimated)

Total Market Size

770.75

655.25

663.0

683.45

Total Local Production

248.50

235.00

237.50

244.60

Total Exports

45.97

46.10

48.80

50.25

Total Imports

568.22

466.35

474.80

489.10

Imports from the U.S.

151.10

116.9

124.0

130.60

Exchange Rate: 1 USD

9.5

15

18 (TBD)

TBD

Total Market Size = (Total Local Production + Total Imports) – (Total Exports)

Data Sources: Total Local Production: Unofficial estimates based on industry reports; Exports/Imports/ Market share: Nosis/Exi-Net export/import database

Statistics were based on following Mercosur HS Codes: 84.13.19.00.1; 8413.91.90.2; 84.73.30.99.910x; 85.40.71.00.100B; 90.11.10.00.000.G; 90.11.90.90.100.N; 90.12.10.10.000.K; 90.12.90; 90.18.1; 90.18.20; 90.18.3; 90.18.4; 90.18.50; 90.18.90; 90.19.20; 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. Note: Import statistic publications by Customs were discontinued in early 2017.

The Argentine medical equipment and device market continues to be dominated by imports. The United States continues to be the leading supplier of imported medical products, with an import market share of 25.1% from the United States, followed by China, Germany, and Japan.

After the gradual easing of import restrictions in the last months of 2015, imports in the medical equipment and device sector experienced double-digit growth. Despite their increase at the beginning of 2016, total healthcare imports eventually subsided towards the end of the year. Imports from the U.S. amounted to US$117 in 2016, and to US$31.2 million in the first quarter of 2017. Growth during 2018 and 2019 depend greatly on the overall economic and investment climate, as well as economic growth.

Main Competitors

More than 2,000 companies sell medical products and equipment in Argentina, either distributors or manufacturers. Brazil poses strong competition since its imports enjoy a 0% tariff under Mercosur. 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

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.

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

Registration Process

ANMAT, the local equivalent to the USFDA, is the Argentine agency responsible for regulating 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. 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.

Product 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

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 would be 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

Most of the import restrictions and limitations on dividend repatriations have been lifted. 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 through several requirements. 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 of government procurement.

Trade Events

Expomedical - “International Trade Show for Products, Services, and Equipment for the Healthcare Sector”

When: September 26-28, 2018

Where: Costa Salguero Exhibition Center, Buenos Aires 

Webpage: www.expomedical.com.ar

ETIF - Congress and exhibition for pharmaceutical, biotechnological, veterinarian and cosmetic science and technology”

When: October 16-18, 2018 (12:00PM-8:00PM)

Where: Costa Salguero Exhibition Center, Buenos Aires

Webpage: http://www.etif.com.ar/index_en.php

Government Links

Argentine Ministry of Health/ Healthcare Plans

ANMAT – Argentine Medical Technology Food and Drug Administration

AFIP - Argentine Tax and Customs Agency

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 who will submit the product registration application as the Registration Holder and will be the point of contact with ANMAT. The importer/representative has to 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
  • Clinical laboratory equipment, molecular biology products, diagnostic reagents
  • 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

44 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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