Leis

The Brazilian Health Regulatory Agency ANVISA has issued Normative Instruction No. 426, dated February 13, 2026, establishing the requirements for data submission...

The healthcare industry is experiencing a data revolution and regulatory affairs are no exception. In a sector defined by complexity, precision, and...

Entering the Brazilian healthcare market represents a powerful opportunity, but also a unique challenge. As one of the largest and most regulated...

In the medical device sector, regulatory approval is a major milestone, but it’s far from the final destination.  Obtaining registration from Anvisa validates a product’s...

The healthcare industry is undergoing one of the most significant transformations in its history. Digitalization, artificial intelligence, and data-driven decision-making are...

In the medical device industry, trust is the foundation of every business relationship between regulators, manufacturers, healthcare providers, and ultimately, patients. ...

From Compliance to Growth: The Power of an Integrated Regulatory Ecosystem  In the medical device industry, success is no longer...

With one of the largest healthcare markets in the world and a highly structured regulatory framework, Brazil stands as the...

Adapting to Change: How New Regulatory Frameworks Are Shaping the Brazilian Medical Device Market  Regulatory evolution is constant in healthcare,...