Device companies were given a tight deadline on Monday to comment on a new proposal that would establish a unique device identification (UDI) system in Australia.
Australia’s Therapeutic Goods Administration (TGA) set forth the 19-page proposal in response to a growing demand to improve how medical devices are tracked throughout the supply chain, with a deadline for industry to respond by 18 February. TGA said that it is “exploring the feasibility of introducing the UDI system in Australia, including options for development of the UDI database.”
TGA called for input on implementation of a globally harmonized UDI system in Australia. Sponsors of most medical devices supplied in Australia would be required to include unique device identifiers and submit data to the Australian UDI database under the proposed system. Amendments for designated agencies to have the authority to issue unique device identifiers is one of the proposed first actions.
The move comes after several other countries in the International Medical Device Regulators Forum (IMDRF) already embarked on transitions to nationwide UDI adoption in recent years. These include the US, Europe, China, Canada and Brazil, among others. Adoption of TGA’s proposed system would result in slightly different UDI adoption across eight out of the current ten IMDRF member countries, with the transitions proving to be more complicated than previously anticipated over a range of technical issues.
“There is now worldwide recognition that, in the interests of patient safety and improved industry outcomes, the ability to unambiguously identify medical devices is essential,” TGA noted. The UDI system’s development and implementation is “widely acknowledged by the industry and regulators as an effective mean of ensuring timely access to complete, accurate and consistent information about medical devices.”’ Other intended benefits relate to supply chain disruption and device interventions…