Wednesday, July 9, 2025

Brazil Enhances Medical Device Tracking with New UDI Regulations

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Brazil’s health regulator, ANVISA, has reinforced the framework for Unique Device Identifiers (UDI) by implementing RDC 591/2021 and extending deadlines through RDC 884/2024. These measures aim to improve the traceability and safety of medical devices and in vitro diagnostics within the Brazilian market.

Implementation of RDC 591/2021

Effective since early 2022, RDC 591/2021 establishes mandatory UDI requirements for medical devices and IVDs in Brazil. The regulation aligns with international standards, distinguishing between UDI-DI for device identification and UDI-PI for production details such as batch numbers and expiration dates. This dual approach ensures comprehensive tracking and management of medical devices throughout their lifecycle, enhancing overall safety and accountability.

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Extended Compliance Deadlines under RDC 884/2024

In July 2024, ANVISA introduced RDC 884/2024, which extends the UDI compliance deadlines based on the risk classification of devices. Class IV devices now have until July 10, 2025, while Class III, II, and I devices receive deadlines extending up to January 10, 2028. Reusable devices requiring UDI direct marking must comply two years post their respective deadlines. These extensions provide manufacturers with additional time to adapt to the new regulations without compromising safety standards.

Inferences:

  • Manufacturers need to update labeling systems to incorporate both UDI-DI and UDI-PI information.
  • Extended deadlines offer a phased approach, easing the transition for high-risk device categories.
  • Enhanced UDI traceability is expected to reduce device recalls and improve patient safety.

ANVISA is set to announce the Sistema de Identificação Única de Dispositivos Médicos (SIUD) through a forthcoming Normative Instruction. This database will centralize UDI information, streamlining regulatory oversight and ensuring seamless data transmission. Public consultations, such as Public Consult 13/2025, have been pivotal in refining these requirements, reflecting industry feedback and practical considerations.

Proactive adoption of these UDI regulations positions Brazilian medical device manufacturers competitively on the global stage. By adhering to international standards, Brazilian companies can facilitate smoother market access and enhance their credibility with international partners. Additionally, the robust UDI system will support continuous monitoring and improvement of medical device safety and efficacy within Brazil.

Embracing these regulatory changes not only ensures compliance but also fosters a culture of accountability and quality within the healthcare industry. Stakeholders are encouraged to engage with ANVISA’s resources and consultations to navigate the transition effectively, ultimately contributing to a safer and more reliable healthcare environment in Brazil.

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