Blog

Introduction  The Brazilian medical device market represents one of the largest opportunities in Latin America, with trade shows and events...

Introduction In June 2025, Anvisa officially introduced the Unique Device Identification System (SIUD), marking a significant milestone in the regulation...

Understanding the New UDI Requirements of RDC 884/2024  The Brazilian Health Regulatory Agency (ANVISA) has set new deadlines for the...

Introduction  Health inspections conducted by ANVISA represent a pivotal moment for companies in the medical device sector in Brazil. With...

Medical devices play a crucial role in the diagnosis, prevention, monitoring, and treatment of diseases. To ensure that these products...

Risk assessment constitutes the methodological foundation for the regulation of medical devices globally, with particular relevance in the Brazilian regulatory...

Brazil’s National Health Surveillance Agency (ANVISA) has recently announced an important change in the risk classification of the ultrasensitive CRP...

The Evolution of the Regulatory Landscape and Technological Innovations  The global medical device market is in constant transformation, driven by...

Regulatory compliance has become a fundamental pillar in the medical device industry, profoundly influencing how companies design, develop, and launch...