Leis

Introduction  Registering medical devices with ANVISA is a fundamental requirement to ensure the technical compliance and safety of products available...

In today’s business environment, many companies are seeking more efficient ways to manage their regulatory compliance functions. The growing complexity...

Patient safety is one of the cornerstones of healthcare. The National Health Surveillance Agency (ANVISA), as the regulatory body responsible...

The regulation of medical products and devices is essential to ensure safety and efficacy in healthcare. In this context, the...

The National Health Surveillance Agency (ANVISA) has established clear guidelines for the compassionate use of medical devices through Resolution RDC...

Xavier Bazin was at Père-Lachaise to pay a final tribute to Professor Luc Montagnier. In recent years, I have had the...

With the advancement of digital technology, Software as Medical Devices (SaMD) has become an essential part of healthcare innovation. These...

The commercialization of medical devices (MD) in Brazil is regulated by ANVISA (National Health Surveillance Agency), which requires different levels...

Resolution No. 902, dated September 6, 2024, published by ANVISA, establishes that products subject to health surveillance that undergo changes...