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:  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  Key Aspects Assessed During ANVISA Inspections  RDC 751/2022 sets specific requirements for quality management systems, including:  ANVISA inspectors rigorously assess:  With the progressive implementation of the UDI system in Brazil, companies must demonstrate:  Harmonization with International Standards  Alignment with Global Regulatory Authorities  Brazilian regulations are increasingly aligned with:  Benefits of Regulatory Harmonization  This alignment facilitates:  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  Phase 2: Action Plan Development  Phase 3: Implementation and Verification  Phase 4: Final 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:  Software as a Medical Device (SAMD)  For SAMD, specific aspects include:  Pre-Audit ROI: Cost-Benefit Analysis  Avoided Costs  Measurable Benefits  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!  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br