05/08/2026
Brazil Regulatory Update: UDI compliance is becoming a critical market access requirement
ANVISA is reinforcing UDI obligations in Brazil and the message is clear:
No UDI submission; no market access.
The new guidance linked to RDC 591/2021 defines how companies must submit, manage, and maintain UDI data within SIUD, Brazil’s official UDI database.
Key points MedTech companies need to know:
-UDI-DI submission is mandatory before commercialization
-UDI data must match ANVISA-approved information
-Companies remain legally responsible, even when using third parties
-UDI records must be continuously updated throughout the product lifecycle
What’s important:
ANVISA only requires submission of the UDI-DI.
But companies must still internally maintain the UDI-PI for traceability purposes.
What’s the difference?
UDI-DI = identifies the product model
Example: all Fill&Care Xtreme 5 ml syringes share the same UDI-DI
UDI-PI = identifies production-specific details
Example: different batches = different UDI-PI
Another critical point:
Companies have only 60 days to correct errors after publication.
After that:
-Only minor updates are allowed
-Major changes may require a completely new UDI-DI
This creates significant operational and regulatory implications.
Changes impacting device identity; such as:
-design modifications
-intended use changes
Require a new UDI-DI and system updates within 30 days.
Why this matters:
UDI is no longer just a labeling requirement.
It is becoming a core pillar of regulatory compliance, traceability, and market continuity in Brazil.
At Arazy Group, we help MedTech companies navigate global regulatory changes and accelerate compliant market access.
Watch the full update: https://hubs.ly/Q04f_Kbt0
More insights: https://hubs.ly/Q04f_zwj0
