Medical devices are of utmost significance in Brazil’s healthcare industry, and the rapidly evolving technological innovations have added a tremendous positive influence. With over 212 million people, Brazil is the largest country in Latin America, and there is a dire need to cater to the right healthcare needs of the population.
The Brazilian medical device sector has recently witnessed substantial growth and offered opportunities globally. However, gaining access to the Brazilian market is prone to significant hurdles with the complex and dynamic regulatory approval system.
This whitepaper focuses on the current Brazilian medical device regulations and sheds light on upcoming regulations and market challenges, which could help overcome the regulatory and market-entry bottlenecks.