Novita Healthcare Limited is pleased to announce that its wholly-owned subsidiary TALI Health Pty Ltd has been issued with an Australian Register of Therapeutic Goods (ARTG) Certificate by the Therapeutic Goods Administration (TGA) for the inclusion of TALI Train as a Class 1 Medical Device.
ARTG inclusion is a legal requirement to supply any medical device in Australia and is an important milestone for Novita as it supports the distribution and adoption of TALI Train nationwide.
Novita Healthcare Managing Director Glenn Smith noted, “The TGA’s inclusion of TALI Health as a medical device is a regulatory milestone as it supports the broader healthcare sector adoption of TALI Train across Australia and is an important step in the global regulatory process for TALI Train. This announcement follows TALI Health’s approval as a registered provider under the National Disability Insurance Scheme (NDIS) and strengthens our competitive advantage as we continue to roll out the commercial release of TALI Train.”
TALI Train is a game-based training program used to treat and monitor childhood difficulties, such as inattention. The program is the first to be designed specifically for the unique needs of children with development disorders such as autism spectrum disorder, ADHD, Down syndrome and non-specific intellectual disability.