The Critical Importance of Pre-Audit in Health Inspections: How to Ensure Compliance with ANVISA Regulations 

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 

1. Proactive Identification of Non-Conformities 

1. Detailed analysis of RDC 751/2022 requirements 

2. Verification of proper GMP implementation 

3. Compliance assessment with MDSAP (Medical Device Single Audit Program) 

2. Strategic Documentation Preparation 

1. Review of IFUs (Instructions for Use) 

2. Validation of laboratory-developed test processes 

3. Organization of FDA registration records when applicable 

3. Specialized Team Training 

1. Training on RDC 67/2009 for health products 

2. Guidance on ANVISA communication procedures 

3. Preparation for specific international regulatory topics 

Key Aspects Assessed During ANVISA Inspections 

1. 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 

2. Good Manufacturing Practices (GMP) 

ANVISA inspectors rigorously assess: 

• Facilities and equipment 

• Manufacturing process control 

• Sterilization systems (when applicable) 

• Material and component control 

• Process validation 

3. 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. 

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