The end of paper at Anvisa! Electronic Protocol is the future of Health Surveillance
The Brazilian Health Surveillance Agency (ANVISA) will fully adopt the electronic document protocol from March 13, 2025, as established by RDC 947/2024. This change will eliminate the need for paper documents, promoting greater agility in document analysis, modernizing processes and reducing operating costs, especially those related to digitization and physical storage.
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.
FDA Proposes Framework to Bolster Credibility of AI Models in Drug Development
The U.S. Food and Drug Administration (FDA) has unveiled a groundbreaking draft guidance aimed at advancing the credibility of artificial intelligence (AI) models in drug and biological product development. This marks a significant milestone as it is the agency’s first formal guidance on AI in this domain, underscoring its commitment to innovation while maintaining rigorous regulatory standards.
ANVISA Publishes Database for Clinical Investigations into Medical Devices
The National Health Surveillance Agency (ANVISA) has announced the launch of a database aimed at clinical investigations related to medical devices. This initiative represents an important milestone in the health sector, promoting greater transparency, efficiency and safety in research carried out in Brazil.
Advantages of Registering Biological and Health Products in Brazil
When it comes to health products in Brazil, understanding Anvisa’s regulatory requirements is essential. Two concepts often mentioned in this context are product registration and notification. Although both are necessary processes to guarantee the safety and efficacy of products available on the market, they have important differences in terms of criteria, requirements and procedures.
ANVISA Updates Rules for Clinical Research: Innovation and Agility in Drug Development.
In November, the National Health Surveillance Agency (ANVISA) announced important changes to its rules for conducting clinical research in Brazil. The new guidelines aim to reduce bureaucratic obstacles, speed up drug development and maintain the strict technical parameters needed to guarantee the safety and efficacy of products. Among the new features is the continuous data submission mechanism, an approach that promises to optimize the analysis and approval processes.
FDA Suggests Collecting data on Ovarian Toxicity in Cancer Drug Trials
The US Food and Drug Administration (FDA) is recommending that sponsors include the collection of data on ovarian toxicity in the development of cancer drugs.
Integration of the Health Surveillance Fee into the Single Foreign Trade Portal: Timetable and Impacts for Brazilian Trade
Anvisa (the National Health Surveillance Agency), in partnership with the Foreign Trade Secretariat (Secex) and the Federal Revenue Service, has announced the integration of the payment of the Health Surveillance Fee into the Single Foreign Trade Portal (Siscomex). This change is part of a move to centralize and digitize foreign trade processes, offering more agility, transparency and simplicity for importers and exporters dealing with products subject to health surveillance.