Currently, there are more than 10,000 medical devices worldwide. 1 Countries must put patient safety first and ensure access to high-quality, safe and effective medical devices. 2,3 The Latin American medical device market continues to grow at a significant annual growth rate. Latin American and Caribbean countries need to import more than 90% of medical devices because the local production and supply of medical devices account for less than 10% of their total demand.
Argentina is the second largest country in Latin America after Brazil. With a population of approximately 49 million, it is the fourth most densely populated country in the region4, and the third largest economy after Brazil and Mexico, with a gross national product (GNP) of approximately US$450 billion. Argentina’s per capita annual income is US$22,140, one of the highest in Latin America. 5
This article aims to describe the capacity of Argentina’s healthcare system and its hospital network. In addition, it analyzes the organization, functions, and regulatory characteristics of the Argentine medical device regulatory framework and its relationship with Mercado Común del Sur (Mercosur). Finally, considering the macroeconomic and social conditions in Argentina, it summarizes the business opportunities and challenges currently represented by the Argentine equipment market.
Argentina’s healthcare system is divided into three subsystems: public, social security and private. The public sector includes national and provincial ministries, as well as a network of public hospitals and health centers, providing free medical services to anyone who needs free medical care, basically people who are not eligible for social security and cannot afford to pay. Fiscal revenue provides funds for the public health care subsystem, and receives regular payments from the social security subsystem to provide services to its affiliates.
The social security subsystem is mandatory, centered on “obra sociales” (group health plans, OS), ensuring and providing health care services to workers and their families. Donations from workers and their employers fund most OSs, and they operate through contracts with private vendors.
The private subsystem includes healthcare professionals and healthcare institutions who treat high-income patients, OS beneficiaries, and private insurance holders. This subsystem also includes voluntary insurance companies called “prepaid drug” insurance companies. Through insurance premiums, individuals, families and employers provide funds for prepaid medical insurance companies. 7 Argentine public hospitals account for 51% of its total number of hospitals (approximately 2,300), ranking fifth among the Latin American countries with the most public hospitals. The ratio of hospital beds is 5.0 beds per 1,000 inhabitants, which is even higher than the average of 4.7 in the Organization for Economic Co-operation and Development (OECD) countries. In addition, Argentina has one of the highest proportions of doctors in the world, with 4.2 per 1,000 inhabitants, exceeding the OECD 3.5 and the average of Germany (4.0), Spain and the United Kingdom (3.0) and other European countries. 8
The Pan American Health Organization (PAHO) has listed the Argentine National Food, Drug and Medical Technology Administration (ANMAT) as a four-level regulatory agency, which means it can be comparable to the US FDA. ANMAT is responsible for supervising and ensuring the effectiveness, safety and high quality of medicines, food and medical devices. ANMAT uses a risk-based classification system similar to that used in the European Union and Canada to supervise the authorization, registration, supervision, monitoring and financial aspects of medical devices nationwide. ANMAT uses a risk-based classification, in which medical devices are divided into four categories based on potential risks: Class I-lowest risk; Class II-medium risk; Class III-high risk; and Class IV-very high risk. Any foreign manufacturer wishing to sell medical devices in Argentina must appoint a local representative to submit the documents required for the registration process. Infusion pump, syringe pump and nutrition pump(feeding pump) as calss IIb medical equipment, must transmit into New MDR by 2024
According to applicable medical device registration regulations, manufacturers must have a local office or distributor registered with the Argentine Ministry of Health to comply with Best Manufacturing Practices (BPM). For Class III and Class IV medical devices, manufacturers must submit clinical trial results to prove the safety and effectiveness of the device. ANMAT has 110 working days to evaluate the document and issue the corresponding authorization; for Class I and Class II medical devices, ANMAT has 15 working days to evaluate and approve. The registration of a medical device is valid for five years, and the manufacturer can update it 30 days before it expires. There is a simple registration mechanism for amendments to the ANMAT registration certificates of category III and IV products, and a response is provided within 15 working days through the declaration of compliance. The manufacturer must also provide a complete history of the device’s previous sales in other countries. 10
Since Argentina is part of Mercado Común del Sur (Mercosur)-a trade zone composed of Argentina, Brazil, Paraguay and Uruguay-all imported medical devices are taxed in accordance with the Mercosur Common External Tariff (CET). The tax rate ranges from 0% to 16%. In the case of imported refurbished medical devices, the tax rate ranges from 0% to 24%. 10
The COVID-19 pandemic has had a great impact on Argentina. 12, 13, 14, 15, 16 In 2020, the country’s gross national product fell by 9.9%, the largest decline in 10 years. Despite this, the domestic economy in 2021 will still show serious macroeconomic imbalances: despite the government’s price controls, the annual inflation rate in 2020 will still be as high as 36%. 6 Despite the high inflation rate and the economic downturn, Argentine hospitals have increased their purchases of basic and highly specialized medical equipment in 2020. The increase in the purchase of specialized medical equipment in 2020 from 2019 is: 17
In the same time frame from 2019 to 2020, the purchase of basic medical equipment in Argentine hospitals has increased: 17
Interestingly, compared with 2019, there will be an increase in several types of expensive medical equipment in Argentina in 2020, especially in the year when surgical procedures that require these equipment were cancelled or postponed due to COVID-19. The forecast for 2023 shows that the compound annual growth rate (CAGR) of the following professional medical equipment will increase:17
Argentina is a country with a mixed medical system, with state-regulated public and private healthcare service providers. Its medical device market provides excellent business opportunities because Argentina needs to import almost all medical products. Despite strict currency controls, high inflation and low foreign investment,18 the current high demand for imported basic and specialized medical equipment, reasonable regulatory approval timetables, high-level academic training of Argentine healthcare professionals, and the country’s excellent hospital capabilities This makes Argentina an attractive destination for medical device manufacturers who wish to expand their footprint in Latin America.
1. Organización Panamericana de la Salud. Regulación de dispositivos médicos [Internet]. 2021 [quoted from May 17, 2021]. Available from: https://www3.paho.org/hq/index.php?option=com_content&view=article&id=3418:2010-medical-devices-regulation&Itemid=41722&lang=es
2. Comisión Económica para América Latina y el Caribe (CEPAL. Las restricciones a la exportación de productos médicos dificultan los esfuerzos por contener la enfermedad porcoronavirus (COVID-19) en América Latina y el Caribe [COVID-19]. //repositorio.cepal.org/bitstream/handle/11362/45510/1/S2000309_es.pdf
3. Organización Panamericana de la salud. Dispositivos médicos [Internet]. 2021 [quoted from May 17, 2021]. Available from: https://www.paho.org/es/temas/dispositivos-medicos
4. Datos macro. Argentina: Economía y demografía [Internet]. 2021 [quoted from May 17, 2021]. Available from: https://datosmacro.expansion.com/paises/argentina
5. Statistician. Producto interno bruto por país en América Latina y el Caribe en 2020 [Internet]. 2020. Available from the following URL: https://es.statista.com/estadisticas/1065726/pib-por-paises-america-latina-y-caribe/
6. The World Bank. Argentina’s World Bank [Internet]. 2021. Available from the following website: https://www.worldbank.org/en/country/argentina/overview
7. Belló M, Becerril-Montekio VM. Sistema de salud de Argentina. Salud Publica Mex [Internet]. 2011; 53: 96-109. Available from: http://www.scielo.org.mx/scielo.php?script=sci_arttext&pid=S0036-36342011000800006
8. Corpart G. Latinoamérica es uno de los mercados hospitalarios másrobustos del mundo. Global Health Information [Internet]. 2018; available from: https://globalhealthintelligence.com/es/analisis-de-ghi/latinoamerica-es-uno-de-los-mercados-hospitalarios-mas-robustos-del-mundo/
9. Argentine Minister Anmat. ANMAT elegida por OMS como sede para concluir el desarrollo de la herramienta de evaluación de sistemasregulationios [Internet]. 2018. Available from: http://www.anmat.gov.ar/comunicados/ANMAT_sede_evaluacion_OMS.pdf
10. RegDesk. An overview of Argentina’s medical device regulations [Internet]. 2019. Available from: https://www.regdesk.co/an-overview-of-medical-device-regulations-in-argentina/
11. Coordinator of the Agricultural Technology Committee. Productos médicos: normativas sobre habilitaciones, registro y trazabilidad [Internet]. 2021 [quoted from May 18, 2021]. Available from: http://www.cofybcf.org.ar/noticia_anterior.php?n=1805
12. Ortiz-Barrios M, Gul M, López-Meza P, Yucesan M, Navarro-Jiménez E. Evaluate hospital disaster preparedness through a multi-criteria decision-making method: Take Turkish hospitals as an example. Int J Disaster Risk Reduction [Internet]. July 2020; 101748. Available from: https://linkinghub.elsevier.com/retrieve/pii/S221242092030354X doi: 10.1016/j.ijdrr.2020.101748
13. Clemente-Suárez VJ, Navarro-Jiménez E, Jimenez M, Hormeño-Holgado A, Martinez-Gonzalez MB, Benitez-Agudelo JC, etc. The impact of the COVID-19 pandemic on public mental health: an extensive narrative commentary. Sustainability [Internet]. March 15 2021; 13(6):3221. Available from: https://www.mdpi.com/2071-1050/13/6/3221 doi: 10.3390/su13063221
14. Clemente-Suárez VJ, Hormeno-Holgado AJ, Jiménez M, Agudelo JCB, Jiménez EN, Perez-Palencia N, etc. Population immunity dynamics due to the group effect in the COVID-19 pandemic. Vaccine [Internet]. May 2020; available from: https://www.mdpi.com/2076-393X/8/2/236 doi: 10.3390/vaccines8020236
15. Romo A, Ojeda-Galaviz C. Tango for COVID-19 requires more than two: analysis of the early pandemic response in Argentina (January 2020 to April 2020). Int J Environ Res Public Health [Internet]. December 24, 2020; 18(1):73. Available from: https://www.mdpi.com/1660-4601/18/1/73 doi: 10.3390/ijerph18010073
16. Bolaño-Ortiz TR, Puliafito SE, Berná-Peña LL, Pascual-Flores RM, Urquiza J, Camargo-Caicedo Y. Changes in atmospheric emissions and their economic impact during the COVID-19 pandemic lockdown in Argentina. Sustainability [Internet]. October 19, 2020; 12(20): 8661. Available from: https://www.mdpi.com/2071-1050/12/20/8661 doi: 10.3390/su12208661
17. Corpart G. En Argentina en 2020, se dispararon las cantidades deequipos médicos especializados [Internet]. 2021 [quoted from May 17, 2021]. Available from: https://globalhealthintelligence.com/es/analisis-de-ghi/en-argentina-en-2020-se-dispararon-las-cantidades-de-equipos-medicos-especializados/
18. Otaola J, Bianchi W. Argentina’s economic downturn eased in the fourth quarter; the economic downturn is the third year. Reuters [Internet]. 2021; Available from: https://www.reuters.com/article/us-argentina-economy-gdp-idUSKBN2BF1DT
Julio G. Martinez-Clark is the co-founder and CEO of bioaccess, a market access consulting company that works with medical device companies to help them conduct early feasibility clinical trials and commercialize their innovations in Latin America. Julio is also the host of the LATAM Medtech Leaders podcast: weekly conversations with successful Medtech leaders in Latin America. He is a member of the advisory board of Stetson University’s leading disruptive innovation program. He holds a bachelor’s degree in electronic engineering and a master’s degree in business administration.
Post time: Sep-06-2021