Leis

For every medical device entering the Brazilian market, classification is the first and most critical regulatory step. This process determines not only...

In the highly regulated healthcare environment, making decisions without updated data and strategic analysis is a risk no company can...

In the medical device industry, no one grows alone.  Regulatory complexity, tax burden, and logistical challenges make it essential to establish strategic...

Bringing a medical technology into Brazil involves much more than logistics and commercialization.Behind every device lies a complex and essential...

New regulatory roadmap defines 161 priority themes for medical devices, pharmaceuticals, and health products  Key Highlights  The Brazilian Health Regulatory...

Anvisa, the National Health Surveillance Agency, is the body responsible for regulating, authorizing, and supervising the entry and commercialization of...

In the healthcare sector, regulation and innovation are not opposing forces, they are complementary. When well-structured, regulation becomes the foundation...

The medical device sector in Brazil faces a scenario of high relevance and natural vocation. There are structural, demographic, and...

The Brazilian medical device market is one of the most complex and promising in the world. With a population of...