ANVISA APPROVES REGULATORY AGENDA 2026-2027
Anvisa has officially approved its Regulatory Agenda for the 2026-2027 cycle, establishing 161 priority themes including 14 dedicated specifically to medical devices. This new roadmap sets the compliance strategy for the next two years, offering manufacturers a clear view of upcoming regulatory changes. Brazil, December 30, 2025 – The Collegiate Board of Anvisa (Dicol) has […]
ANVISA 2025 MANUAL FOR HEALTH-USE MATERIALS REGISTRATION
ANVISA’s new 2025 manual for health-use materials registration establishes strict new standards for medical device submissions in Brazil, aligned with RDC 751/2022. By enforcing a “summary rejection” policy for incomplete dossiers and clarifying digital submission rules, the agency aims to eliminate regulatory queues and accelerate market access for compliant manufacturers. Brazil, December 30, 2025 — […]