Argentina - HealthcareArgentina - Healthcare
Capital: Buenos Aires
Population: 43 million
GDP*: $580 billion (est. 2015)
Currency: Peso (ARS)
Healthcare expenditures in Argentina have traditionally accounted for approximately 7 percent of GDP, among the highest in the region. Imports in the overall healthcare sector have been estimated to account for around 70-75 percent of the total market. The United States continues to lead the Argentine import market of medical products and equipment, and currently holds almost 27 percent market share (2015), particularly in higher-end technology products.
Argentina is experiencing a new political and economic environment since the change of administration last December 2015. The new government took some highly needed measures that will benefit trade, such as eliminating import restrictions, removing limitations on dividend repatriation and floating and unifying the exchange rate. Growth in 2016 and beyond depends greatly on the overall investment climate and on government policy responses after reducing subsidies and combatting a 20-30 percent projected inflation.
Argentina remains a key market for U.S. exports to Latin America. The U.S. is one of Argentina’s top three major trading partners, and historically ranks among the top three source countries in FDI.
While total U.S. exports to Argentina fell 14 percent in 2015, under the previous restrictive import regime, the gradual lifting of restrictions for key sub- sectors allowed imports in the healthcare industry to rise from US$440 million in 2014 to US$ 568 million in 2015. Imports from the U.S. rose 40 percent in 2015, growing from US$107.7 in 2014 to US$151.1 million in 2015.
Imports of medical products must be performed by an importer registered with ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica), the Argentine equivalent to the U.S. Food and Drug Administration (FDA), as a frequent importer of medical equipment. Imported products generally appear under the name of the local registered importer who will fulfill the registration process as a representative of the U.S. company.
The Mercosur common external tariff (CET) applies to imports from countries outside the MERCOSUR area (Argentina, Brazil, Uruguay and Paraguay). The CET currently averages 14 percent for medical products plus 0.5 percent in a statistics fee.
Current Market Trends
The Argentine medical equipment and device market continues to be dominated by imports. Imports in the healthcare sector increased in general in 2015, with imports from the U.S. growing significantly. Total medical equipment and supplies imports amounted to approximately US$ 568.2 million in 2015, a 30 percent increase from 2014 figures.
Imports from the U.S. amounted to US$151.1 million, increasing 40 percent in 2015 vis-à-vis 2014. The United States continues to be the leading supplier of imported medical products and holds a 27percent market share (up from 24 percent in 2014), particularly in high-technology products.
During the first five months of 2016, total medical imports amounted to $200 million, with imports from the U.S. accounting for $48 million. Total medical imports in 2016 are expected to continue growing, and according to this trend, imports from the United States may continue to grow in 2016 and beyond.
Note: Statistics were based on following Mercosur HS Codes: 84.13.19.00.1; 8418.104.22.168; 22.214.171.124.910x; 85.40.71.00.100B; 90.11.10.00.000.G; 126.96.36.199.100.N; 188.8.131.52.000.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; 184.108.40.206.100.N; 220.127.116.11.200.U
More than 2,000 companies sell medical products and equipment in Argentina, of which 25 percent are manufacturers and 75 percent are importers. Brazil poses strong competition since imports enjoy a zero percent tariff under Mercosur. U.S., Japanese and European-made equipment 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-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, and scales, etc.
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.
Opportunities for U.S. exports in this sector include middle- and high-end technology products that do not compete with locally manufactured ones, among which are electro-diagnostic equipment, ultrasound equipment, and other medical devices. There may also be potential in the market for implants, stents, cardiac valves, pacemakers, clinical laboratory equipment, molecular biology products, diagnostic reagents, specialized catheters and cannulas, x-ray equipment, and other specialized disposables. Among these products, the largest exports of U.S. products in 2015 were in the following HS Codes categories in 2015: 9018.90.99.190.Q; 9018.90.99.990J; 9018.39.29.900.J; 9018.39.29.900.C; 9022.30.00.200.K; 9018.14.10.100.Z; 9018.90.10.190.U; & 9019.20.90.900.F.
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 24 months.
Product classification can be: Class I, II, III and 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:
- Letter or Certificate of Representation/Distribution in Spanish with an apostille
- Users or Technical manual (in Spanish)
- ER Matrix (Essential Requirements)
- Brochures and labels
Additional documents that may be required are: electrical safety certification, manufacturing flowchart process and description; sterilization methods and parameters; scientific or clinical evidence report. Further description of ANMAT regulations on medical products can be found at: www.anmat.gov.ar
Most of the import restrictions and limitations on dividend repatriation have been lifted. The previous 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 license.
This Resolution is supplemented by Resolution Nº 5/2015, by the Ministry of Production, which provides details on AILs and NAILs, the information required from importers, and which products require NAILs. (Annexes II through XVII). Under the SIMI, importers will need to present the information requested through the Argentine Tax and Customs - AFIP’s website, (http://www.afip.gob.ar/simi/). The declaration of imports will have a valid term of 180 days as of approval.
Importation of used and refurbished medical equipment is either forbidden or highly restricted through several requirements. It is generally not recommended for US exporters and distributors.
Expomedical-“International show for products, services, and equipment”
When: September 28-30, 2016
Where: Centro Costa Salguero, Buenos Aires
ETIF-“Congress and exhibition for pharmaceutical, biotechnological, veterinarian and cosmetic science and technology”
When: October 18-20, 2016 (12:00PM-8:00PM)
Where: Centro Costa Salguero, Buenos Aires
CADIEM – Argentine Chamber of Importers and Manufacturers of Medical Equipment
Address: Hipólito Yrigoyen 636 Piso 6 Oficina “B” CP: 1086 C.A.B.A.
Phone: 5411- 4342-3107 / 4342- 6017
Argentine Ministry of Health/ Healthcare Plans
AFIP - Argentine Tax and Customs Agency
ANMAT – Argentine Medical Technology Food and Drug Administration
U.S. Commercial Service Contact Information
Name: Liliana Paz
Position: Senior Commercial Specialist
Argentina Healthcare Trade Development and Promotion