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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...
Clinical studies are a crucial step in the medical device development and approval process, ensuring their safety and efficacy before...
The rapid advancement of technology in the medical device industry has dramatically transformed healthcare delivery, while also presenting new challenges...
In recent years, the medical device industry has undergone a profound transformation driven by technological innovations. Technologies such as artificial...
Introduction Registering medical devices in Brazil requires meticulous preparation of technical documentation for approval by the National Health Surveillance Agency...
March 21, 2025 ANVISA Introduces New Regulatory Framework for Medical Device Identification The Brazilian Health Regulatory Agency (ANVISA) has launched...
