Marketing Medical Devices in Latin America – The Three Awoken giants of Latin America

The current economic outlook in Latin America presents a unique opportunity for medical device manufacturers, particularly as 2017 marks the first year of economic growth for all three of the regions’ largest economies, Brazil, Mexico and Argentina since 2013. Combined, the three have a total population of 377 million and a GDP of 3.5 trillion dollars, about the size of Germany’s GDP (3.3 trillion) and significantly larger than India’s GDP (2 trillion).

Brazil the region’s largest economy, rebounds after more than 2 years of economic contraction. Brazil’s economy is expected to grow 0.5% in 2017 and 1.8% in 2018, signaling a return to more favorable business environment for medical device manufacturers. In Mexico, the regions’ second largest economy, economic growth continues despite unrealized fears raised by the Trump election. The economy there is expected to grow 1.8% in 2017 and 2.5% in 2018. Meanwhile, business prospects have largely improved in the region’s third largest economy, Argentina. Since the election of Macri in 2016, the president has opened the nation for business after years of protectionist populist policies. 2017 is expected to bring back economic growth after a period of reform with a projected 2.7% growth. In 2018, the projection is 3.2%.

Good economic news from the region mean increased business opportunities for medical device manufacturers both inside and outside the region, but economic indicators only paint half the picture. The current regulatory environment in these countries plays a pivotal role when it comes to placing products in the market. All three countries use a 4-tier classification system based on the risk of the device and regulatory requirements increase along with the classification like in the United States. The following table provides an overview of the regulatory agencies in Brazil, Mexico and Argentina.

Like the US FDA, the regulatory agency in these three countries is in charge of regulating medicinal products as well as medical devices and in order to market medical devices in these countries, manufacturers must make a submission to the regulatory agency and receive marketing approval. Unlike the US, marketing approval for medical devices expires and must be renewed every 5 years in these three countries, the exception being Class I and II devices in Brazil. In Mexico and Argentina, COFEPRIS and ANMAT provide certain regulatory ‘shortcuts’ for medical devices that have been approved in the United States, Canada, EU, Australia or Japan, a route referred to as equivalence based approval. However, such ‘shortcut’ is not offered by Brazil’s ANVISA. Furthermore, manufacturers of Class III and IV devices for the Brazilian market are subject to an ANVISA GMP inspection before their devices can enter the Brazilian market.

In next week’s blog post, we will take a deeper look into Brazil and see what are the benefits and challenges of bringing medical devices to Latin America’s largest economy as well as an overview of ANVISA and its medical device regulatory framework.