Date: February 18, 2026
The ANVISA has published Normative Instruction (IN) No. 426/2026, establishing the requirements for transmission and management of data within Brazil’s Unique Device Identification (UDI) database.
The regulation strengthens traceability and transparency for medical devices marketed in Brazil and reinforces post-market control mechanisms.
Entry into force: March 1, 2026
Non-compliance will constitute a sanitary infraction under applicable legislation.
Mandatory UDI data submission to Unique Device Identification System (SIUD)
Manufacturers must transmit UDI data to the Unique Device Identification System (SIUD) before commercialization.
Compliance deadlines by risk class :
- Class IV : 3,5 years (01/09/2029)
- Class III : 4 years (01/03/2030)
- Class II : 5 years (01/03/2031)
- Class I : 6 years (01/03/2032)
Key regulatory requirements
1. Data consistency obligation
UDI data submitted must be fully equivalent to the medical device information approved by ANVISA.
The sanitary authorization holder remains legally responsible for this alignment.
2. Flexible submission formats
Companies may transmit data:
- Individually
- In bulk via structured electronic files
3. Correction window
Errors may be corrected within 60 days after publication of the data.
4. UDI-DI Deactivation
The UDI-DI must be deactivated within 30 days when:
- The product is no longer marketed
- The authorization expires
- The regulatory approval is canceled
5. Third-Party submission allowed
Companies may appoint third parties to submit UDI data on their behalf, while retaining full regulatory responsibility.
6. Voluntary submission for legacy devices
Devices already marketed and in use at the time the regulation enters into force may have UDI data submitted voluntarily at any time.
Official sources
ANVISA – Normative Instruction No. 426/2026