Brazil Anvisa UDI System 2025 Launch: Medical Device Regulation Update

On June 30, 2025, Brazil’s National Health Surveillance Agency (Anvisa) officially launched its Unique Device Identification (UDI) System, known as Siud, during an event held at its headquarters in Brasília. The initiative marks a significant regulatory milestone aimed at improving the traceability and safety of medical devices across Brazil.

This national system aligns Brazil with the International Medical Device Regulators Forum (IMDRF) standards, supporting better post-market surveillance and facilitating global interoperability.

View the official Anvisa announcement

What Is UDI and Why It Matters

UDI is an international standard that assigns a unique code to each medical device, making it easier for authorities, manufacturers, and healthcare providers to:

• Track devices throughout their lifecycle

• Improve recall efficiency

• Enhance post-market monitoring

• Protect patient safety

In Brazil, UDI requirements were established by RDC 591/2021, and its main obligations come into force in July 2025. The regulation mandates the use of the Siud database, a centralized platform developed by Anvisa for UDI registration and monitoring.

UDI Requirements Now in Effect

From July 2025, companies marketing medical devices in Brazil must:

• Register products in the Siud database

• Apply standardized UDI labels

• Align with global classification frameworks based on risk level and intended use

These changes enhance visibility into the origin, distribution, and use of medical devices, supporting more informed decisions by both regulators and healthcare professionals.

Download the Siud User Manual (Portuguese PDF)

Why This Matters

The implementation of the UDI system in Brazil is a step toward a more transparent, efficient, and safer healthcare system. By aligning with international standards and engaging stakeholders at every level, Anvisa reinforces its commitment to public health and patient protection.

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