TGA provides a new UDI system consultation paper

The Australian device regulator, TGA, has released a new Unique Medical Device Identification (UDI) system consultation paper as part of the medical device reforms. This is the second consultation on this topic and seeks feedback on the next level of detail to be considered in the design and implementation of a UDI system for medical devices in Australia. In particular, the TGA is seeking feedback on the benefits that a UDI system could deliver to the broader healthcare system, a staged implementation approach and the regulatory burden on alignment with other international models. A link to the consultation paper is here: The consultation will be open for 8 weeks and closes on 18 November 2020.