ANVISA has officially launched the public consultation process for the Regulatory Agenda 2026-2027, representing a fundamental strategic opportunity for medical device manufacturers and industry companies to influence Brazilian regulatory priorities for the next two years.
Timeline and Participation Process
Consultation Period: August 15 to September 15, 2025 Target Audience: Society and entities of the National Health Surveillance System (SNVS) Method: Electronic forms according to Public Call Notice 10, dated 8/14/2025
Preliminary List: 115 Strategic Regulatory Themes
The preliminary list of the 2026-2027 Regulatory Agenda presents a comprehensive set of 115 regulatory themes, strategically distributed as:
- 97 themes migrated from the 2024-2025 Agenda
- 18 new themes proposed by ANVISA’s technical areas
This composition offers unprecedented opportunities for medical device authority stakeholders to influence critical areas, including:
- GMP (Good Manufacturing Practices) and quality standards
- SAMD (Software as Medical Device) and technology regulations
- Implementation and updates of RDC 751/2022
- Laboratory developed tests and regulatory validation
- Medical device registration processes and regulatory efficiency
- UDI (Unique Device Identification) and traceability
- MDSAP (Medical Device Single Audit Program)
Guidelines for Effective Participation
The health products regulatory authority establishes clear criteria for effective contributions:
- Clear and well-motivated contributions according to participation manual guidelines
- Specific submissions by macro-theme – separate forms for each ANVISA area of operation (medical devices, medicines, food, etc.)
- Robust technical foundation to effectively influence the analysis of the Agency’s technical units
Important: The more well-founded the manifestations, the greater their contribution to technical analysis and theme prioritization by the medical products agency.
Strategic Webinar for Industry Professionals
Date: Thursday, August 21, 2025 Time: 10:00 AM (Brasília time) Theme: “Building the 2026-2027 Regulatory Agenda: Preliminary Theme List Notice”
Free access – no prior registration required. This session will present fundamental elements of AR 2026-2027 and specific guidelines for submitting contributions.
Available Documentation
ANVISA provides two versions of the preliminary list:
- Summarized version in PDF format for quick consultation
- Detailed version in Excel spreadsheet for in-depth analysis
Strategic Importance for the Sector
The Regulatory Agenda functions as an essential planning instrument that provides predictability and transparency to normative regulatory activity. For companies and specialized consultants, this means:
- Advance preparation for regulatory changes
- Strategic adaptation to new requirements
- Active participation in building a stable regulatory environment
- Alignment of business strategies with regulatory developments
Comprehensive Sectoral Impact
This public consultation directly impacts stakeholders involved in:
- Regulatory consulting and regulatory affairs
- Compliance with the health sciences authority
- Focus Anatel for devices with telecommunications components
- Identifier software and technological solutions for health
- Laboratory tests and diagnostics
- Manufacturing and distribution of medical devices
Finalization Process
It is essential to understand that this consultation on the preliminary list represents a moment of collecting contributions to support the construction of the final list of themes, which will be approved by ANVISA’s Collegiate Board by the end of 2025. Therefore, this is not yet the definitive version of the 2026-2027 Regulatory Agenda.
Value of Social Participation
The participatory construction of the Regulatory Agenda is a prominent guideline at ANVISA, reflecting society’s contributory value for aligning the Agency’s regulatory actions with its mission to protect and promote population health.
This public consultation represents a unique opportunity to shape the Brazilian regulatory environment, ensuring that industry needs are considered in regulatory planning for the next two years.
Strategic Conclusions:
- 115 regulatory themes under public consultation
- One-month window for contributions (Aug 15 – Sep 15)
- Separate submissions by macro-theme
- Webinar: August 21, 10:00 AM
- Final approval expected by end of 2025
- Focus on evidence-based contributions for maximum impact
Reference Source: ANVISA Official News – Regulatory Agenda 2026-2027
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