Brazil’s UDI System Nears Enforcement: What Medical Device Manufacturers Must Know for 2025 and Beyond

Brazil’s national Unique Device Identification (UDI) system is advancing toward full implementation. Under RDC 591/2021, ANVISA requires all manufacturers to assign and register UDI information for all medical devices sold in Brazil. The UDI system, known as SIUD (Sistema de Identificação Única de Dispositivos Médicos), will become fully operational upon publication of the final Normative Instruction (currently under public consultation as CP 1.313/2025), which is expected in mid-2025.

SIUD’s release will trigger the enforcement of the first UDI compliance deadlines. Note that all class IV devices must present the UDI identification code on their labels as of July 10, 2025, even though SIUD’s release is still pending.

Brazil medical device UDI compliance deadlines

RDC 884/2024 extended the original transition period deadlines in RDC 591/2021. The deadlines are assigned by risk class:

• Class IV: July 10, 2025 – UDI device labeling required as of this date

• Class III: January 10, 2026

• Class II: January 10, 2027

• Class I: January 10, 2028

For reusable devices that require direct marking on the device itself, enforcement will apply two years after the respective class deadlines.

Brazil UDI labeling requirements

Specific labeling requirements vary based on device type, risk class, and intended use. However, general UDI labeling requirements are consistent with IMDRF guidelines.  

Each UDI must include a Device Identifier (UDI-DI) specific to the device model and packaging level, and a Production Identifier (UDI-PI) reflecting data such as lot number or expiration date. It must appear on the device label and applicable packaging, excluding transport containers, using both a machine-readable (AIDC) and human-readable (HRI) format, in line with standards from an ANVISA-designated issuing agency (i.e., GS1 or HIBCC). Manufacturers are also required to implement quality system controls to ensure proper UDI assignment prior to market placement.

SIUD functionality and expected release

ANVISA released a preliminary user manual for SIUD in May 2025, outlining database functions such as device registration, updates, and retirement. While labeling requirements include UDI-PI, the coded UDI-PI is not entered into the database. However, manufacturers must indicate which types of production control elements are included in the UDI on the product, such as lot number, serial number, expiration date, manufacturing date, etc. Other key functions include:

• Each product model requires an individual UDI-DI registration; no bulk upload is currently available (though mass submission and M2M data exchange are under development).

• Users can save draft submissions (retained for 180 days) and make limited edits post-publication.

• Fields like legal manufacturer, catalog number, and GMDN code are mandatory.

• Manufacturers must specify a publication date for UDI-DI data; if not, data is made public the day after submission.

• A limited grace period is available after publication for corrections or edits.

• Registration holders can authorize third-party users (e.g., foreign manufacturers or consultants) to submit or manage UDI-DI data.

• Third-party access is traceable and cannot be permanently deleted; users are restricted to authorized product scopes.

How you can prepare for Brazil UDI compliance

The UDI rollout is intended to improve traceability, support faster recalls, and align Brazil’s regulatory infrastructure with international standards. For companies already compliant with the FDA’s GUDID or European EUDAMED systems, much of the required data may already exist, though formatting, language, and database fields may need to be adjusted for SIUD.  

However, companies responsible for product registration in Brazil should ensure the following are in place ahead of the applicable deadlines:  

• a class-based inventory to confirm compliance deadlines for your product portfolio,  

• validated UDI-DI and UDI-PI assignment processes,  

• label updates to reflect the required carriers,  

• and internal SOPs for submitting and maintaining data in SIUD.

Again, if you have Class IV devices on the market in Brazil, UDI labeling compliance is mandatory as of July 10, 2025.  

For official resources:

• RDC 591/2021 (in Portuguese)

• RDC 884/2024 - New UDI Deadlines (in Portuguese)

• Preliminary SIUD User Manual (in Portuguese)

Brazil medical device compliance experts

Pure Global offers targeted support to help manufacturers prepare for Brazil’s new UDI requirements. Our team provides end-to-end assistance: from evaluating your product portfolio and assigning compliant UDI-DI and UDI-PI elements, to ensuring labeling accuracy and managing SIUD submissions on your behalf. Learn more about Brazil ANVISA labeling requirements.

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