Introduction
Health inspections conducted by ANVISA represent a pivotal moment for companies in the medical device sector in Brazil. With increasing regulatory stringency and the implementation of new guidelines, proper preparation through specialized medical device consulting services has become essential for business success.
The Current Landscape of Health Inspections in Brazil
The National Health Surveillance Agency (ANVISA) has intensified its inspection activities, especially following the publication of RDC 751/2022, which establishes stricter criteria for Good Manufacturing Practices (GMP) for medical devices. This regulation, which replaces previous standards, marks a milestone in aligning Brazilian regulatory practices with international standards.
Main Challenges Faced by Companies
During health inspections, companies frequently encounter:
- Non-conformities related to technical documentation
- Failures in implementing quality management systems
- Inadequacies in manufacturing and control processes
- Deficiencies in product traceability (UDI)
- Issues with SAMD (Software as a Medical Device) and identifier software
The Pre-Audit Strategy: Ensuring Regulatory Success
What Is a Pre-Audit?
A pre-audit is a comprehensive and systematic assessment of a company’s processes, documentation, and infrastructure, conducted by medical device regulatory experts before the official ANVISA inspection.
Proven Benefits of Pre-Audit
- Proactive Identification of Non-Conformities
- Detailed analysis of RDC 751/2022 requirements
- Verification of proper GMP implementation
- Compliance assessment with MDSAP (Medical Device Single Audit Program)
- Strategic Documentation Preparation
- Review of IFUs (Instructions for Use)
- Validation of laboratory-developed test processes
- Organization of FDA registration records when applicable
- Specialized Team Training
- Training on RDC 67/2009 for health products
- Guidance on ANVISA communication procedures
- Preparation for specific international regulatory topics
Key Aspects Assessed During ANVISA Inspections
- Quality Management System
RDC 751/2022 sets specific requirements for quality management systems, including:
- Document and record control
- Management responsibility
- Resource management
- Product realization
- Measurement, analysis, and improvement
- Good Manufacturing Practices (GMP)
ANVISA inspectors rigorously assess:
- Facilities and equipment
- Manufacturing process control
- Sterilization systems (when applicable)
- Material and component control
- Process validation
- Traceability and Unique Device Identification (UDI)
With the progressive implementation of the UDI system in Brazil, companies must demonstrate:
- Complete product traceability
- Proper unique identification systems
- Integration with regulatory databases
Harmonization with International Standards
Alignment with Global Regulatory Authorities
Brazilian regulations are increasingly aligned with:
- FDA (Food and Drug Administration), United States
- Health Products Regulatory Authority, Ireland
- Health Sciences Authority, Singapore
- Medical Products Agency, Sweden
- Medical Device Authorities across various European countries
Benefits of Regulatory Harmonization
This alignment facilitates:
- International registration processes
- Mutual audit acceptance
- Reduced regulatory costs
- Expanded access to global markets
Specialized Sectors and Industry Events
Technology and Innovation
For companies working with advanced technologies, including SAMD and identifier software, pre-audit is especially critical due to the regulatory complexity of these products.
Participation in Industry Events
Events like Hospitalar 2024 highlight the growing importance of regulatory compliance in the sector. Participation in such events, combined with a strong compliance strategy, strengthens companies’ competitive position.
Implementing an Effective Pre-Audit Program
Phase 1: Initial Assessment
- Complete regulatory diagnosis
- Compliance gap mapping
- Regulatory risk analysis
Phase 2: Action Plan Development
- Prioritization of non-conformities
- Implementation timeline
- Allocation of necessary resources
Phase 3: Implementation and Verification
- Execution of identified improvements
- Team training
- Inspection simulation
Phase 4: Final Preparation
- Final documentation review
- Team briefing
- Physical environment preparation
Regulatory Communication and Updates
The Importance of the Regulatory Newsletter Radar
Staying up to date through reliable sources such as specialized newsletters is essential to monitor regulatory changes and prepare effectively for inspections.
Communication Channels with Authorities
Establishing effective contact channels with ANVISA and other regulatory authorities helps clarify doubts and proactively resolve regulatory issues.
Specific Considerations for Different Device Types
High-Risk Products
For high-risk medical devices, pre-audit should include:
- Validation of critical processes
- Strict sterilization control
- Documentation of clinical studies
Software as a Medical Device (SAMD)
For SAMD, specific aspects include:
- Software validation
- Version control
- Specialized technical documentation
- Cybersecurity testing
Pre-Audit ROI: Cost-Benefit Analysis
Avoided Costs
- Regulatory fines and penalties
- Product launch delays
- Post-inspection rework costs
- Market reputation loss
Measurable Benefits
- Reduced inspection time
- Higher approval rates
- Accelerated registration processes
- Strengthened regulatory credibility
Conclusion
Implementing a robust pre-audit program is a strategic investment for companies in the Brazilian medical device sector. With the increasing complexity of ANVISA regulations and the need to align with international standards, proper preparation through specialized medical device consulting is not just advisable—it is essential for business success.
RDC 751/2022 and other current regulations establish a strong regulatory framework that, when properly implemented through pre-audit processes, ensures not only regulatory compliance but also operational excellence and competitiveness in both domestic and international markets.
Find out more about BPO in RA!
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