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 approved the Regulatory Agenda (RA) for the 2026-2027 cycle, which will officially come into effect on January 1, 2026. This document serves as the primary planning tool for the agency, defining which regulations (RDCs) will be updated or created over the next two years. For medical device manufacturers, the agenda signals a shift toward greater transparency and public engagement, with 14 specific topics prioritized for the sector.
Key Updates in Anvisa Regulatory Agenda 2026-2027
The new agenda reflects a significant effort to clear the backlog of regulatory updates while introducing new standards based on public demand.
- 14 Priority Themes for Medical Devices: A focused list of regulatory topics has been carved out specifically for the MedTech sector.
- Migrated & New Topics: Of the 161 total themes, 97 are carried over from the previous agenda, while 38 are entirely new, 10 of which were suggested directly by the public.
- Record Public Participation: The consultation phase saw nearly triple the participation of the previous cycle, with over 2,000 responses driving the selection of these themes.
Impact on Medical Device Manufacturers
The approval of this agenda provides a predictable timeline for regulatory teams, allowing for better resource allocation and strategic planning.
- Predictability: Manufacturers now have a defined list of regulations that will change, reducing the risk of surprise compliance hurdles.
- Transparency: The agenda was built using the “Agrupa-PS” AI tool to organize public contributions, ensuring that industry and consumer voices were integrated into the priority list.
- Continuous Monitoring: Anvisa has committed to maintaining a “Regulatory Topics and Proposals Monitoring Panel”, allowing companies to track the daily progress of these 14 themes.
How Companies Can Comply
To align with the new 2026-2027 roadmap, manufacturers and regulatory professionals should:
- Identify the 14 Device Themes: Review the specific list of medical device topics to determine which product lines will be affected.
- Monitor the Panels: regularly check Anvisa’s monitoring panels for updates on the specific regulations relevant to your portfolio.
- Prepare for 2026: Use the time before the January 1, 2026 effective date to audit current compliance strategies against upcoming changes.
External links: Official Anvisa Regulatory Agenda Announcement