IMDRF Releases Key Guidance Documents for Medical Device Software

IMDRF Releases Key Guidance Documents for Medical Device Software

The International Medical Device Regulators Forum (IMDRF) has released two key guidance documents to support the regulation of medical device software. These include Good Machine Learning Practice for Medical Device Development: Guiding Principles (IMDRF/AIML WG/N88 FINAL:2025) and Characterization Considerations for Medical Device Software and Software-Specific Risk (IMDRF/SaMD WG/N81 FINAL:2025). These documents aim to enhance global regulatory harmonization and assist medical device manufacturers in navigating compliance requirements for software-based and AI-driven technologies.

EMA Launches Early Scientific Advice Program for High-Risk Medical Devices

EMA Launches Early Scientific Advice Program for High-Risk Medical Devices

The European Medicines Agency (EMA) has launched a new Early Scientific Advice (ESA) program aimed at supporting the development of high-risk medical devices. This initiative seeks to provide manufacturers with timely regulatory guidance, ensuring that innovative medical technologies meet the necessary safety and efficacy standards before reaching the market.

Exploring the Diversity of Medical Devices for Health Promotion in Brazil

Overview: Brazil stands out as the main market for medical devices in Latin America, with an established, albeit complex, regulatory system. Medical products in the country are regulated by the National Health Surveillance Agency (ANVISA). Against this backdrop, we explore the main types of medical devices and their specific applications within the Brazilian context. Introduction: […]

Health Product Labelling Requirements for Imported Products into Brazil

"Discover the critical role that packaging plays in the development of cosmetic products."

The import of Health products into Brazil is subject to various regulations, with proper labelling being a crucial part of this procedure. These regulations cover the current standards for labelling imported products, outlining the responsibilities of importers and the essential elements that must be included on labels.