Navigating the Global Shift: Brazil's UDI System and the Future of Medical Device Regulation
Introduction
The landscape of medical device regulation worldwide is experiencing a transformative shift. Driven by a collective push for greater transparency, improved patient safety, and more effective post-market surveillance, regulators across the globe are adopting harmonized standards to better identify and trace medical devices throughout their lifecycle. Central to this evolution is the implementation of Unique Device Identification (UDI) systems—a global standard designed to streamline device tracking, enhance safety protocols, and facilitate regulatory compliance.
While early adopters like the United States Food and Drug Administration (FDA) and the European Union (via MDR and IVDR) have paved the way, Brazil’s National Health Regulatory Agency, ANVISA, has recently taken decisive steps to align its regulatory framework with these international best practices. The introduction of Brazil’s comprehensive UDI system marks a pivotal milestone for the Latin American healthcare market, creating new opportunities and presenting complex challenges for MedTech and HealthTech companies aiming to operate within this dynamic environment.
This blog explores the key aspects of Brazil’s UDI regulation, its implications for stakeholders, and how companies can strategically navigate this evolving landscape.
Understanding Brazil’s UDI Regulatory Framework
Legal Foundations: RDC 591/2021 and RDC 884/2024
Brazil’s UDI requirements are primarily governed by two important pieces of legislation:
- Resolution RDC 591/2021: Establishes the foundational requirements for implementing the UDI system, defining what a UDI is, and setting obligations for manufacturers and other stakeholders.
- Resolution RDC 884/2024: Provides clarifications, updates, and additional guidance to ensure smooth implementation of the initial resolution.
Together, these regulations form a comprehensive framework that specifies the structure, application, and responsibilities related to UDI in Brazil.
Core Components of Brazil’s UDI System
At the heart of the system is a dual-component code, comprising:
- Device Identifier (DI): A mandatory, fixed alphanumeric code that uniquely identifies the specific device model and manufacturer.
- Production Identifier (PI): A conditional, variable segment providing detailed production info such as batch/lot number, serial number, expiration date, and manufacturing date.
This structure ensures precise tracking of every device, from high-risk implants to low-risk consumables.
UDI Labeling and Marking Requirements
The regulations specify that the UDI must be displayed:
- On the device label and packaging.
- Directly marked on the device itself, especially for reusable devices that undergo reprocessing.
UDI presentation must include:
- Human-readable format: Plain text on labels.
- Machine-readable format: Barcodes or 2D Data Matrix codes for electronic scanning.
National UDI Database: Sistema Nacional de UDI (Siud)
A cornerstone of Brazil’s UDI system is the Siud, a centralized digital repository that stores all relevant data about registered medical devices:
- UDI-DI
- Manufacturer details
- Device model and specifications
- Regulatory information
Manufacturers are responsible for submitting and maintaining accurate data in Siud, making it a critical pillar for compliance.
Implementation Timeline and Compliance Deadlines
Brazil’s phased rollout provides clear compliance deadlines based on device risk classification:
- Class IV (High-Risk): July 2025
- Class III (High-to-Moderate Risk): July 2026
- Class II (Moderate-to-Low Risk): July 2027
- Class I (Low-Risk): July 2028
Manufacturers must develop strategic plans to meet these deadlines, considering the specific requirements for each class.
Impacts and Opportunities
Benefits for Stakeholders
- Patients: Enhanced safety through quicker recalls, reduced errors, and greater transparency.
- Healthcare Providers: Improved inventory management, accurate medical records, and easier adverse event reporting.
- Manufacturers: Greater supply chain visibility, efficient recall processes, and tools to combat counterfeiting.
Challenges to Overcome
Implementing UDI in Brazil involves significant changes:
- Investments in labeling and data management systems.
- Updating quality management systems.
- Training staff on new processes.
- Navigating complex data submission procedures, often involving accredited issuing agencies like GS1.
Multinational companies face added complexity due to differing global UDI regulations, necessitating a strategic approach.
Partnering for Success: How Pure Global Supports Your UDI Journey
Navigating Brazil’s UDI regulations requires expertise, local knowledge, and technological support. Pure Global specializes in end-to-end regulatory consulting tailored for the medical device and IVD industries. Our services include:
- Developing robust regulatory strategies.
- Conducting comprehensive gap analyses.
- Creating customized implementation plans.
- Leveraging AI and data tools for efficient documentation and data submissions.
- Acting as your local representative in Brazil to liaise with ANVISA.
Our team’s deep understanding of ANVISA’s nuances ensures a smooth transition, helping you meet deadlines and optimize compliance.
Why Choose Pure Global?
- Extensive local expertise with global reach.
- Cutting-edge technology for streamlined processes.
- Personalized support for startups, scale-ups, and multinational corporations.
- Proven track record in global market access.
Conclusion
Brazil’s adoption of a comprehensive UDI system signals a broader move toward harmonized, transparent, and safer medical device regulation worldwide. For MedTech and HealthTech companies, this shift offers an opportunity to strengthen their supply chains, enhance patient safety, and gain a competitive edge in Latin America’s vibrant healthcare market.
However, success hinges on strategic planning, compliance readiness, and leveraging the right partnerships. With the support of experienced regulatory experts like Pure Global, companies can navigate this complex landscape efficiently and position themselves for sustained growth.
To learn more about how we can assist you in achieving seamless UDI compliance in Brazil—and unlocking access to the global market—contact us at info@pureglobal.com or visit pureglobal.com.
