Latin America's Evolving Medical Device Market

Qmed Staff

September 5, 2013

2 Min Read
Latin America's Evolving Medical Device Market

While a significant number of regions in Latin America are still in the early stages of developing their medical device industries, eight countries stand out as strong players. These countries include Argentina, Colombia, Venezuela, Brazil, Mexico, Cuba, Chile and Peru. Combined, these regions have a total population of 497 million. With a combined GDP of $5.4 trillion this year, growth in these countries is expected to be steady in coming months. While Venezuela's growth potential is stymied by a lagging local currency, many of these markets are poised for strong growth.

While private sector growth represents the strongest market for medical device manufacturers, the public health sector is expanding in many parts of Latin America. There are a significant number of opportunities for medical device suppliers and manufacturers; however, it can be challenging to understand how to develop these markets.

In terms of size, Brazil forms the largest medical device market in Latin America. Mexico comprises the second-largest, followed by Venezuela and Columbia. Argentina is the fifth largest medical device industry in Latin America.

Excluding Mexico and Brazil, medical device regulations are lax in large parts of Latin America. Since these developing markets have not yet reached maturity, regulatory systems in these regions are still being consolidated. As of now, both Mexico and Brazil have mature regulatory systems for medical devices.Mercosur is a political and economic agreement between Bolivia, Venezuela, Uruguay, Paraguay, Brazil and Argentina. For the most part, Mercosur members follow the regulatory rules of Argentina and Brazil, allowing for a moderate degree of harmonization. In addition, Andean member states like Peru and Columbia base their medical device regulation on Brazil's model. Mexico looks north to the United States for its regulations, following recommendations issued by FDA officials.While Brazil has a strong and healthy domestic industry, most regions in in Latin America are dependent on device imports. Countries like Chile, Argentina and Brazil import a significant number of high-tech medical devices. Countries like Venezuela, Mexico and Peru import more consumable medical devices.Excluding Mexico, medical exports in most of Latin America are low. In total, Mexico comprises 90% of all regional exports. Mexico's large export market is due to its maquiladora manufacturing operations. Maquiladora is a type of manufacturing that takes place in free-trade zones. In these free-trade zones, Mexico can import medical device components and raw materials for manufacturing without paying tariffs or import taxes. Assembled devices or finished components are then exported back to the United States.Based on the total size of Brazil's medical device market, exports in this country are very low. While exports have increased 200% over the past eight years, there is still a significant trade deficit in this country.

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