Introduction
The Brazilian medical device market presents significant opportunities for international manufacturers, but navigating the regulatory landscape requires expertise in ANVISA requirements. Understanding the role of the Brazilian Registration Holder (BRH) is crucial for foreign companies seeking to establish a successful presence in Brazil’s healthcare sector.
What is a Brazilian Registration Holder (BRH)?
The Brazilian Registration Holder (BRH) is a legal entity established in Brazil that assumes responsibility for registering medical devices and conducting post-market surveillance activities on behalf of foreign manufacturers. This regulatory requirement ensures that international companies maintain local representation for compliance and communication with ANVISA.
Key Responsibilities of the Registration Holder
The BRH serves as the official interface between foreign manufacturers and Brazilian regulatory authorities, such as INMETRO, ANATEL, and ANVISA. Core responsibilities include:
- Registration Management: Maintaining medical device registrations and ensuring compliance with current RDCs (Resolutions of the Collegiate Board).
- Post-Market Surveillance: Implementing adverse event reporting systems and managing product recalls.
- Regulatory Communication: Acting as the primary ANVISA contact for all regulatory matters.
- Quality System Oversight: Ensuring compliance with GMP and supporting MDSAP audit processes.
Regulatory Framework and Current Requirements
Key Regulations Governing BRH Operations
RDC 751/2022 – Current Registration Framework
RDC 751/2022 represents the current standard for medical device registration in Brazil, establishing comprehensive requirements for product classification, clinical evidence, and quality management systems.
RDC 665/2022 – GMP Requirements
RDC 665/2022 continues to serve as the foundation for Good Manufacturing Practices (GMP) in Brazil, aligning with international GMP standards and supporting MDSAP recognition.
International Harmonization Efforts
Brazil’s participation in the Medical Device Single Audit Program (MDSAP) demonstrates a commitment to international harmonization. This program allows manufacturers to undergo a single audit that satisfies regulatory requirements across multiple jurisdictions.
Laboratory-Developed Tests (LDTs)
The BRH plays a critical role in supporting the registration and compliance of Laboratory-Developed Tests, including:
- Clinical evidence requirements for diagnostic devices
- Translation and localization of IFUs (Instructions for Use)
- Post-market surveillance specific to diagnostic applications
Choosing the Right BRH Partner
Essential Criteria for BRH Selection
When evaluating potential BRH partners, manufacturers should consider:
- Regulatory Expertise: Deep understanding of ANVISA requirements and RDCs
- Industry Experience: Proven track record in medical device consulting
- Infrastructure: Robust quality management systems supporting GMP compliance
- Communication: Effective ANVISA contact capabilities and multilingual support
Due Diligence Process
A thorough assessment should include:
- Evaluation of the BRH’s regulatory compliance history
- Review of quality management system certifications
- Assessment of post-market surveillance capabilities
- Analysis of communication protocols and response times
Implementation Strategy
Establishing BRH Relationships
Successful BRH implementation requires:
- Legal Structure: Comprehensive agreements defining roles and responsibilities
- Quality Agreement: Clear specifications for GMP compliance and MDSAP support
- Communication Protocols: Established procedures for ANVISA interactions
- Training Programs: Ensuring BRH staff understand specific product requirements, when applicable
Market Access Benefits
Accelerated Registration Timelines
An experienced BRH can significantly reduce registration timelines through:
- Pre-submission consultation with ANVISA
- Optimized dossier preparation
- Efficient response to regulatory inquiries
- Strategic use of recognition pathways
Cost Optimization
Professional BRH services provide cost benefits through:
- Reduced registration rejection rates
- Efficient post-market surveillance systems
- Streamlined GMP compliance processes
- Optimized resource allocation
Future Regulatory Developments
Emerging Trends
Brazil’s medical device regulations continue to evolve, with key developments including:
- Enhanced implementation requirements for UDI
- Expanded regulatory pathways for SaMD
- Strengthened participation in MDSAP
- Increased focus on cybersecurity for connected devices
Conclusion
The Brazilian Registration Holder (BRH) serves as a critical partner for foreign medical device manufacturers seeking success in Brazil’s dynamic healthcare market. By understanding BRH requirements, selecting qualified partners, and implementing robust compliance strategies, international companies can effectively navigate ANVISA regulations while focusing on their core mission of improving patient outcomes.
Success in Brazil’s medical device market requires more than regulatory compliance—it demands strategic partnership with experienced medical device consultants who understand ANVISA’s complexities and can provide the local expertise needed for sustainable market access.
Contact us to discuss your specific needs and discover how our BRH services can accelerate your path to success in the Brazilian market. Let us handle the regulatory complexities while you focus on bringing innovative healthcare technologies to Brazilian patients.
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
