Navigating Brazil's Evolving Regulatory Framework for In-Vitro Diagnostic Devices
Entering the Brazilian healthcare market offers significant opportunities for MedTech and HealthTech companies, thanks to its large population and dynamic healthcare system. However, successfully navigating the country’s regulatory landscape—particularly for in-vitro diagnostic (IVD) devices—requires a solid understanding of ANVISA’s requirements and recent regulatory changes.
This blog provides an in-depth overview of Brazil’s updated IVD regulations under Resolution RDC 830/2023, which came into effect in June 2024. We’ll explore how these changes impact market entry, compliance pathways, and ongoing post-market obligations, equipping your company with the knowledge to succeed in this complex environment.
The Role of ANVISA in Brazil’s Medical Device Market
The Agência Nacional de Vigilância Sanitária (ANVISA) is Brazil’s regulatory authority responsible for ensuring the safety, quality, and efficacy of all medical products, including IVD devices. As the gatekeeper, ANVISA enforces strict registration processes, manufacturing standards, and post-market surveillance to protect public health.
Understanding ANVISA's regulatory approach is vital for MedTech and HealthTech companies aiming to establish a foothold in Brazil’s healthcare sector.
Key Changes Introduced by RDC 830/2023
The most transformative update in Brazil’s IVD regulation landscape is the introduction of Resolution RDC 830/2023, which replaced the previous RDC 36/2015. This new regulation aligns Brazil’s IVD classification and requirements with international standards, especially the European Union's In Vitro Diagnostic Regulation (IVDR 2017/746).
1. Risk-Based Classification System
The cornerstone of RDC 830/2023 is the adoption of a risk-based classification system, dividing IVDs into four classes:
- Class A: Low individual and public health risk
- Class B: Moderate individual risk and/or low public health risk
- Class C: High individual risk and/or moderate public health risk
- Class D: High individual and public health risk
This classification determines the regulatory pathway, required documentation, and level of scrutiny.
2. Regulatory Pathways: Notificação vs. Registro
- Classes A and B (Notificação): These devices follow a Notificação process, which is streamlined and faster. It involves submitting basic documentation; ANVISA does not conduct an in-depth pre-market review. However, manufacturers must keep documentation ready for audits.
- Classes C and D (Registro): These require a comprehensive Registro (Registration) process, entailing detailed pre-market review and approval, including extensive technical documentation and potentially on-site inspections.
3. Technical Documentation and Performance Evaluation
All IVDs must compile a Technical Dossier that substantiates safety and performance. Under RDC 830/2023, this dossier now requires:
- Detailed device design, composition, manufacturing process, and intended use
- A Performance Evaluation Report (PER) with analytical and clinical performance data
- A risk management file aligned with ISO 14971
- Stability studies
- Complete labeling and Instructions for Use (IFU), translated into Brazilian Portuguese
The PER is a living document, necessitating updates throughout the product lifecycle based on post-market data.
The Critical Role of a Brazil Registration Holder (BRH)
Foreign manufacturers must appoint a Brazil Registration Holder (BRH)—a local entity responsible for:
- Submitting registration applications
- Holding the registration
- Managing post-market activities such as vigilance reporting and recalls
Choosing a reliable and experienced BRH is crucial, as they control the registration process and transfer can be complex.
Additional Regulatory Requirements
1. Good Manufacturing Practices (B-GMP)
Class C and D devices must have manufacturing sites certified under Brazilian Good Manufacturing Practices (B-GMP). ANVISA conducts site inspections, which can be lengthy, although participation in the Medical Device Single Audit Program (MDSAP) can expedite the process.
2. Certification for Electrical and Wireless Devices
- Devices with electrical components or analyzers may require INMETRO certification for electrical safety.
- Wireless-enabled devices need ANATEL certification for telecommunications compliance.
3. Electronic Submission and Fees
All submissions are made electronically through ANVISA’s portal. The BRH manages uploading documentation, paying fees (which vary by risk class and company size), and responding to review queries.
Timelines and Post-Market Vigilance
- Notification process: Typically a few months.
- Registration process: Can extend over a year, especially for high-risk devices or B-GMP certification.
Post-market obligations are continuous. Manufacturers must implement post-market surveillance systems, actively monitor device performance, report adverse events within strict deadlines, and update documentation regularly.
Why Partner with Experts? How Pure Global Can Help
The complexities of RDC 830/2023—risk classification, extensive documentation, local legal representation, and ongoing compliance—can be overwhelming. That’s where Pure Global steps in.
We offer end-to-end regulatory solutions, including:
- Acting as your trusted Brazil Registration Holder
- Developing tailored regulatory strategies
- Preparing flawless Technical Dossiers with advanced AI tools
- Guiding you through B-GMP certification
- Managing post-market surveillance and vigilance activities
Our local expertise and technology-driven approach streamline your pathway to Brazil, reducing time-to-market and ensuring ongoing compliance.
Conclusion
Navigating Brazil’s regulatory landscape for IVD devices requires a clear understanding of recent changes and a strategic approach. RDC 830/2023’s risk-based classification, extensive documentation requirements, and mandatory local representation underscore the importance of expert guidance.
Partnering with experienced local specialists like Pure Global can transform this complex process into a manageable step within your global expansion plan. Ready to explore the Brazilian market? Contact us at info@pureglobal.com or visit pureglobal.com to learn more about how we can assist your journey.
Embark on your Brazilian regulatory journey with confidence—trust Pure Global as your local partner for success!
