New regulatory roadmap defines 161 priority themes for medical devices, pharmaceuticals, and health products
Key Highlights
The Brazilian Health Regulatory Agency (Anvisa Brasília) approved its Regulatory Agenda for 2026-2027 on December 10, 2024, establishing a comprehensive framework of 161 priority regulatory themes for the next two years.
Agenda Composition
- 97 themes migrated from the 2024-2025 Agenda
- 26 themes for periodic updates
- 38 new themes (28 from Anvisa technical areas, 10 from public consultation)
Priority Distribution
- Pharmaceuticals: 38 themes
- Food products: 35 themes
- Cross-cutting issues: 18 themes
- Medical devices: 14 themes
Unprecedented Public Participation
The consultation process achieved record engagement:
- 647 submissions received (3x more than previous cycle)
- 2,079 total manifestations from stakeholders
- 10 new themes incorporated based on public input
- AI-powered analysis using the Agrupa-PS tool
Impact on Medical Device Sector
Companies engaged in medical device consulting should prepare for regulatory updates in:
- GMP (Good Manufacturing Practices) requirements
- MDSAP harmonization initiatives
- SaMD (Software as a Medical Device) frameworks
- UDI (Unique Device Identification) implementation
- Laboratory developed tests regulations
Post-market surveillance enhancement
Implementation Timeline
Formal publication: Decree in Diário Oficial da União
Effective date: January 1, 2026
Monitoring tools: Daily and quarterly tracking panels available
Strategic Recommendations
Organizations should:
- Review current compliance status against anticipated requirements
- Engage medical device consulting experts for gap analysis
- Monitor agenda progress through Anvisa’s portal
- Participate in future public consultations
- Prepare quality management systems for GMP updates
Conclusion
The 2026-2027 Regulatory Agenda represents a significant milestone for Brazilian healthcare regulation. With strong emphasis on medical devices, pharmaceuticals, and cross-sector harmonization, companies must begin strategic planning now to ensure compliance readiness by January 2026.
The unprecedented level of public participation 647 submissions generating over 2,000 manifestations demonstrates the maturity of Brazil’s regulatory system and the importance of stakeholder engagement in shaping health policy.
Note: The complete translated list of themes is available at Anvisa’s official portal. / English Version
This article provides informational guidance and does not replace consultation with qualified regulatory professionals or official regulatory documents.
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