Stewart Eisenhart and Evangeline Loh Among emerging medical device markets worldwide, Brazil has

Stewart Eisenhart and Evangeline Loh

Among emerging medical device markets worldwide, Brazil has become a high-priority target for many foreign manufacturers due to its sheer size as well as its stable regulatory system.

Brazil boasts the largest Latin American medical device market, with revenues of $4.8 billion as of 2010, and the country’s medical device imports have risen at a steady pace—more than $4 billion in 2011, up from $3.7 billion in 2010 and $2.8 billion in 2009.1 Unlike some emerging medical device markets, however, Brazil also features a robust and active regulatory framework managed by the National Health Surveillance Agency, or ANVISA. All medical device manufacturers must register with ANVISA prior to marketing their devices in the country, which requires considerable effort on the part of companies and sponsors. In addition, foreign manufacturers should appreciate that Brazil has a fairly sizeable domestic medical device sector that exports to other North and South American markets.