Regulatory Framework Change: Companies Have Until May 30, 2026 to Transition
Executive Summary
In a significant regulatory development, ANVISA (Brazilian Health Regulatory Agency) has officially approved a new norm regulating the sanitary classification of sodium chloride-based products intended for nasal cavity irrigation as medical devices. This decision, formalized through a decision from Collegiate Board (DICOL) on October 29, 2025, establishes clear guidelines for the transition from medicine to medical device classification, providing legal certainty and regulatory predictability for the sector.
Historical Context and Regulatory Evolution
From Drugs to Medical Devices
The reclassification journey began in 2023 when these products were initially reclassified from medicines to medical devices through ANVISA’s Collegiate Board Decision expressed in Vote No. 128/2023/SEI/DIRE3/ANVISA. However, until now, this change existed only in internal votes and deliberations without a specific normative instrument.
Key Provisions of the New Regulation
1. Explicit Regulatory Classification
The resolution establishes that sodium chloride-based products for nasal irrigation are classified as:
Risk Class IV Medical Devices according to RDC 751/2022 (or subsequent updates)
This classification applies to:
- Powder formulations for preparation
- 0.9% ready-to-use saline solutions
2. Structured Transition Process
The regulation introduces comprehensive rules covering:
Compliance Deadlines
- Final deadline: May 30, 2026
- Companies must cancel medication notifications and regularize products as medical devices by this date
- After May 30, 2026: All remaining medication notifications will be automatically canceled by ANVISA
Inventory Depletion Conditions
Clear guidelines for:
- Existing packaging materials
- Product labels
- Instructions for use (IFUs)
- Batches produced during the transition period
Commercialization Criteria
Specific rules governing the sale of products manufactured during the transition period, ensuring market continuity while maintaining safety standards.
Major Innovation: CBPF (GMP) Recognition
Good Manufacturing Practices Certification (CBPF)
One of the most significant advances in the new regulation is the acceptance of CBPF for drugs manufacturers to qualify these products as medical devices. This provision:
✓ Eliminates a major regulatory barrier reported by manufacturers
✓ Streamlines the compliance process
✓ Reduces duplicative certification requirements
As noted by Director Daniela Marreco, the regulation’s rapporteur: “The Good Manufacturing Practices requirements for both health products and medications are sufficient to ensure the quality and safety of these products.”
This pragmatic approach recognizes that existing quality systems adequately address product safety concerns, facilitating a smoother transition for compliant manufacturers.
Implementation Timeline and Action Plan
Critical Milestones for Companies
| Phase | Deadline | Required Actions |
| Preparation | December 2025 | Gap analysis, documentation review, team training |
| Transition | January-April 2026 | Cancel medication notifications, submit medical device registration |
| Compliance | May 30, 2026 | All products must be registered as medical devices |
| Automatic Cancellation | After May 30, 2026 | ANVISA will cancel remaining medication notifications |
Recommended Implementation Steps
Phase 1: Assessment (Immediate)
- Review current product portfolio affected by the regulation
- Identify all active medication notifications for sodium chloride products
- Conduct gap analysis against RDC 751/2022 requirements
- Evaluate existing CBPF status
Phase 2: Documentation (November 2025 – January 2026)
- Prepare technical documentation for medical device registration
- Update product labeling and IFUs according to medical device standards
- Review and update quality management system documentation
- Ensure compliance with RDC 751/2022 classification criteria
Phase 3: Regulatory Submission (February – April 2026)
- Submit medical device registration applications
- Cancel medication notifications systematically
- Coordinate with ANVISA regarding transition queries
- Plan inventory and market strategy
Phase 4: Market Transition (Through May 2026)
- Manage existing inventory under transition rules
- Introduce new medical device packaging
- Train sales and distribution teams
- Communicate changes to healthcare professionals and consumers
Regulatory Requirements for Medical Device Registration
Classification Under RDC 751/2022
Companies must ensure their products meet Class IV medical device requirements, including:
Essential Documentation
- Technical file demonstrating safety and performance
- Risk management documentation
- Clinical evaluation or clinical investigation data
- Post-market surveillance plan
- Instructions for use and labeling compliant with medical device standards
Quality System Requirements
- Good Manufacturing Practices certification (existing medication CBPF accepted)
- Quality management system aligned with ISO 13485 (when applicable)
- Regular internal audits and management reviews
Registration Process
According to RDC 751/2022, Class IV devices require:
- Comprehensive technical documentation submission
- ANVISA evaluation and approval
- Post-registration surveillance commitments
- Periodic renewal according to regulatory timelines
Strategic Implications for the Industry
Benefits of the New Framework
1. Regulatory Clarity
- Eliminates ambiguity in product classification
- Provides clear compliance pathway
- Reduces regulatory uncertainty
2. Operational Efficiency
- Leverages existing CBPF for medications
- Streamlines quality system requirements
- Reduces time and cost of compliance
3. Market Stability
- Transition rules prevent market disruption
- Clear inventory depletion guidelines
- Maintains product availability during transition
4. Legal Security
- Official normative instrument provides enforceable framework
- Clear deadlines and requirements
- Reduced risk of non-compliance penalties
Challenges to Address
Companies should proactively manage:
- Coordination of multiple product transitions simultaneously
- Training of personnel on medical device regulations
- Communication with healthcare providers and consumers
- Supply chain adjustments for new labeling and packaging
Compliance Checklist for Companies
☐ Immediate Actions (November 2025)
- Identify all affected products in portfolio
- Review current regulatory status of each product
- Verify CBPF status and validity
- Assign internal project team for transition
☐ Short-Term Actions (December 2025 – February 2026)
- Develop technical documentation for medical device registration
- Update labeling and IFUs to medical device standards
- Prepare post-market surveillance system
- Engage with ANVISA for clarification on specific questions
☐ Medium-Term Actions (March – May 2026)
- Submit medical device registration applications
- Cancel medicines notifications systematically
- Implement new quality management procedures
- Train all relevant personnel
☐ Ongoing Compliance (Post-May 2026)
- Maintain medical device quality system
- Execute post-market surveillance plan
- Prepare for periodic regulatory renewals
- Monitor regulatory updates and guidance
Expert Consulting Support
Navigating this significant regulatory transition requires specialized expertise in both medicines regulations and medical device regulatory affairs. Professional consulting can provide:
Gap Analysis Services
- Comprehensive assessment of current compliance status
- Identification of documentation and system gaps
- Customized action plans
Registration Support
- Technical file preparation
- ANVISA submission management
- Response to regulatory queries
- Timeline optimization
Quality System Implementation
- Adaptation of existing quality systems to medical device requirements
- Training programs for personnel
- Internal audit preparation
- CBPF maintenance strategies
Strategic Planning
- Portfolio transition roadmaps
- Risk mitigation strategies
- Market communication plans
- Regulatory intelligence updates
Additional Resources and References
Primary Regulatory Framework
- RDC 751/2022: Medical Device Registration and Notification Requirements
- RDC 576/2021: Cancellation procedures and timelines
- Vote 128/2023/SEI/DIRE3/ANVISA: Original reclassification decision
ANVISA Resources
- Official ANVISA website: www.gov.br/anvisa
- Medical device guidance documents
- Frequently Asked Questions (FAQ) sections
- Contact information for technical support
Conclusion
The formal approval of this new regulation represents a milestone in Brazilian regulatory evolution, bringing alignment with international best practices and providing the necessary legal framework for the saline solutions market. The acceptance of medication CBPF for medical device qualification demonstrates ANVISA’s pragmatic approach to regulatory efficiency without compromising safety standards.
Key Takeaways:
- Companies have a clear deadline of May 30, 2026 for compliance
- The regulation provides comprehensive transition rules minimizing market disruption
- GMP recognition significantly reduces compliance barriers
- Early action and strategic planning are essential for successful transition
Organizations should begin implementation activities immediately to ensure smooth transition and avoid automatic cancellation of medication notifications. Engaging with medical device consulting specialists and staying informed through official ANVISA communications will be critical for success.
- Source: ANVISA Official Communication – October 30, 2025
For specialized support in medical device registration, quality system implementation, and regulatory compliance with RDC 751/2022 and MDSAP requirements, contact regulatory affairs experts with proven experience in ANVISA procedures and international standards.
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