Why should you consider Latin America as a market for your products?
Latin America encompasses over 20 countries spread throughout North, Central, and South America, and its predominant language is Spanish, but Portuguese (Brazil) and French are also used.
Over the years, Latin America has become of interest to medical device and pharmaceutical industries from other countries around the world due to their economically similar areas that are moving towards integration agreements like Mercosul (Southern Common Market), ALADI (Latin American Integration Association), and have strategic characteristics for business.
In 2021, the American continent was responsible for buying 69% of medical devices that the Brazilian industry exported, with 40.6% represented by Latin America, showing a growth of 26.59% compared to the previous year. In 2022, from January to May, there was an increase of 17% compared to the same period in 2021.
Today, Latin America does not have a health authority that harmonizes all the health regulation of these countries, so we list below the regulatory agencies of each country:
- Argentina ANMAT. National Administration of Drugs, Food, and Medical Technology
- Bolivia AGEMED – State Agency for Medicines and Health Technologies
- Brazil ANVISA. National Health Surveillance Agency. Ministry of Health
- Chile ISP – Institute of Public Health
- Colombia INVIMA – National Institute for the Surveillance of Drugs and Food
- Costa Rica Ministry of Health of Costa Rica
- Cuba CECMED – Center for State Control of Drugs, Equipment and Medical Devices
- Ecuador ARCSA – National Agency for Regulation, Control, and Sanitary Surveillance
- El Salvador National Directorate of Medicines
- Guatemala Department of Regulation and Control of Pharmaceutical Products and Related
- Haiti DNM/MT – Directorate of Pharmacy, Medicine, and Traditional Medicine
- Honduras Health Regulation Agency (ARSA)
- Mexico COFEPRIS – Federal Commission for Protection against Health Risks
- Nicaragua General Directorate of Health Regulation
- Panama Directorate of Drugs and Pharmacy
- Paraguay National Directorate of Health Surveillance
- Peru DIGEMID, General Directorate of Medicines, Supplies, and Drugs
- Dominican Republic National Directorate for Drug Control
- Uruguay Ministry of Public Health
- Venezuela IHRR, Rafael Rangel National Hygiene Institute.
It’s important to note that through the World Health Organization (WHO), there are indicators that assess the maturity of these regulatory agencies, with level 4 being the highest level of competence and level 1 being the lowest possible level.
Currently, in Latin America, the following agencies are considered level 4: ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), INVIMA (Colombia), CECMED (Cuba), and COFEPRIS (Mexico).
To register and sell your medical devices/health products in these countries, count on Passarini Group. Our team of experts is available for any clarifications.
But if you still have any doubts, please contact our specialists at: contato@passarini.com.br.
Passarini Group
Published on: 03/28/2023 – Source: Brazilian Health Devices
