ANVISA on High Alert: The Use of Injectable Cosmetics and the Strict Enforcement of Good Manufacturing Practices in Brazil
The Brazilian Health Regulatory Agency (ANVISA) is intensifying enforcement against the dangerous practice of using cosmetics as injectables and reinforcing the strict adherence to Good Manufacturing Practices (GMP). Understand the regulatory implications for the cosmetics and medical device sectors in Brazil and the associated risks.
Building Transparency: FDA Experts Offer Essential Tips for Assembling SBOMs in Medical Devices
The recent discussion among experts at the Medtech conference, highlighted by the FDA, underscores the critical importance of the Software Bill of Materials (SBOM) in medical device cybersecurity. Although SBOM generation tools are still in their early stages, the consensus is clear: manufacturers must start working immediately on assembling these documents. The SBOM is now an essential regulatory requirement for “cyber devices” and crucial for managing risks and ensuring patient safety. Experts emphasize the need for simplification, the inclusion of key partners in the process, and attention to the details of the human-readable format, which complements the machine-readable format required by the FDA.
ANVISA explains how drug safety is assessed in the pharmacovigilance cycle
Pharmacovigilance is essential to ensure that medicines marketed in Brazil continue to be safe and effective over time. Even after approval and market entry, these products continue to be monitored through a structured cycle that involves detecting adverse events, analyzing risks and adopting corrective measures. In this blog, you will understand how this process coordinated by ANVISA works, what the roles of each agent involved are and why the participation of society is so important.
ANVISA Opens Public Consultation on New Regulatory Framework for Medical Devices in Brazil
Brazil’s national health surveillance agency, ANVISA, has launched a targeted public consultation as part of its effort to revise and modernize the regulatory framework for medical devices. This initiative aims to align Brazilian regulations with international best practices, enhance patient safety, and foster innovation. Stakeholders across the health and regulatory sectors are invited to submit their contributions and insights.