Global Medical Device UDI Update: Progress in Australia and Brazil

Medical device regulators in Australia and Brazil have recently reported progress in implementing their respective Unique Device Identification (UDI) frameworks, helping to further advance transparency and traceability of devices in healthcare markets.

Australia: UDI requirements for high-risk devices take effect

First, the Therapeutic Goods Administration (TGA) has implemented new UDI requirements for higher-risk Class III and Class IIb medical devices in Australia. As of July 1, 2026, affected manufacturers must place a UDI carrier on device labels and higher levels of packaging, according to the TGA. Manufacturers must then submit UDI-Device Identifier (UD-DI) information to the Australian UDI Database, or AusUDID. 

As previously reported by Emergo by UL, these requirements are part of a three-year phased implementation of UDI requirements in Australia:

• Class IIa device manufacturers face a July 1, 2027 deadline for UDI carrier and AusUDID submission requirements.
• Class Is device manufacturers must meet these requirements starting July 1, 2028.

Phased compliance timeframes for direct marking of devices and submission of Direct Marking Device Identifier (UD-DI) data to AusUDID will begin taking effect January 1, 2028 for Class III devices. 

Similar UDI requirements will begin taking effect for in vitro diagnostic (IVD) products in Australia starting July 1, 2028 for Class 3 and Class 4 IVDs.

Brazil: SIUD UDI database regulation issued

The latest TGA UDI developments follow the release of regulations for the ANVISA UDI database (SIUD) in Brazil earlier in 2026. 

Issued by Brazil’s medical device regulator ANVISA in February 2026, Normative Instruction (IN) No. 426/2026 lays out rules for use of SIUD by Brazilian Registration Holders (BRH) and manufacturers as well as compliance deadlines according to risk class of devices.

Manufacturers of high-risk Class IV devices must begin transmitting UDI information to SIUD on September 1, 2029, followed by March 1, 2030 for Class III devices, March 1, 2031 for Class II devices and March 1, 2032 for Class I devices in Brazil.

Conclusion: Progress towards a more harmonized global UDI framework

Although the Australian TGA and Brazil ANVISA are in different stages of UDI regulatory implementation, their alignment with UDI frameworks in other markets including the US and European Union will help drive more robust transparency and post-market surveillance of medical devices and IVDs globally.