ANVISA’s New Rules for Post-Market Monitoring of Cosmetics: The Impact of RDC 894/2024
The National Health Surveillance Agency (ANVISA) has published two documents on the new rules for post-market monitoring of cosmetics. The Inspection Manual for Good Cosmetic Surveillance Practices and the Questions and Answers on RDC 894/2024 will support the implementation of the new regulatory guidelines and strengthen the safety of cosmetic products in Brazil.
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
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.
Stakeholders Ask FDA to Harmonize Guidelines for Oligonucleotide-Based Therapies
The biopharmaceutical industry and other stakeholders are pressuring the US Food and Drug Administration (FDA) to harmonize its regulatory guidelines for oligonucleotide-based therapies. The request aims to eliminate discrepancies in the development, manufacturing and approval requirements for these innovative treatments, which have shown great potential in the fight against various genetic and infectious diseases.
ANVISA Publishes RDC 936/2024: New Guidelines for Health Products and Their Implications for Medicine
The National Health Surveillance Agency (ANVISA) has launched Collegiate Board Resolution (RDC) 936/2024, which establishes new guidelines for the regulation of health products. These changes aim to improve the safety and efficacy of products used in medicine, directly impacting health professionals and patients.
Health Canada Makes Clinical Information on Medical Devices Publicly Accessible
Health Canada Makes Clinical Information on Medical Devices Publicly in a significant move toward greater transparency in healthcare, Health Canada (HC), the country’s medical device regulator, has announced that clinical information submitted in support of medical device applications is now publicly available. This development marks a crucial step in empowering healthcare professionals, researchers, and the general public with access to critical data.