Oct 20, 2015

Most people don’t realize it, but taken together, the major Latin American countries—Brazil, Mexico, Colombia, Chile, and Argentina—represent the third largest economy in the world, with a healthcare expenditure comparable to China and India. Their combined GDP exceeds $4.25 trillion and the medical device industry has grown into a significant combined market. It’s no surprise that medical device companies have their eye on Latin America.

Starting points: Mexico & Brazil

Mexico is the second largest country south of the US and a favorable starting point for medical device companies pursuing the Latin American market. With the 13th largest GDP in the world and a $3 billion medical device industry, Mexico has great potential for companies with new devices. It is a member of the North American Free Trade Association (NAFTA) and has a friendlier regulatory climate, without the import duties (for American and Canadian companies) that can be burdensome in the Brazilian market.

Brazil is the largest economy in Latin America and also boasts the strongest medical device market. It has the 6th largest GDP in the world and a $4 billion medical device industry. But doing business in Brazil presents some challenges. Brazil imposes high tariffs on imports compared to its neighbors, so medical device companies outside Latin America will face considerable duty fees. Products imported from MERCOSUR countries (Argentina, Bolivia, Brazil, Paraguay, Uruguay, and Venezuela) are generally without duties as part of the bloc’s free trade agreements.

Sources of growth

Latin America is known for its large “lifestyle” procedures market, which includes surgical and non-surgical aesthetics and ophthalmology. Brazil and Mexico have two of the largest aesthetic markets in the world, with more plastic surgery procedures in Brazil and Mexico combined than in the United States. Vision correction is another driving factor in Latin America.

Pursue regulatory clearance with urgency

Seek approval in Latin America as soon as CE marking or FDA clearance is obtained in order to maximize your future options. Companies may delay registering in Latin America until they decide to enter the market, but this can be a costly mistake as the region has a painstaking regulatory process.

The complexity of the approval process depends on the risk classification of the product. Each national agency has guidelines that define risk classification based on the technology and the ensuing regulatory process. However, the guidelines are similar to those in other parts of the world.

Choosing a distributor

Finding a quality distributor in Latin American countries is one of the biggest challenges when selling your device in this region. The medical device distribution industry is highly fragmented with hundreds of small distribution companies. International device companies often rely on distributors to play a more strategic role as well as provide a commercial infrastructure. However, trusting your foreign distributor to price, position, and market your device can make or break your success in Latin America. It is critical to screen potential distributors and choose carefully.

Medical device companies in the USA, Europe, and beyond are looking at Latin America to expand their market reach. The strength of the current industry and its projected growth in Latin America make it an exciting option for ambitious manufacturers. However, the region presents some challenges and, while trade unions like MERCOSUR provide some continuity, the regulatory environment varies between countries. Medical device companies should pursue registration in Latin America as soon as possible if there is any chance of selling your device in this market. But you should complete thorough research and planning before investing in importation and distribution.

A special thank you to medical device business intelligence provider TforG for providing much of  the information contained in this article.


  • Ritza Suazo and Helgert Van Raamt