The Australian Government is undertaking a significant program of reform to the regulation of therapeutic goods in Australia. The reforms will continue to improve the safety, performance, and quality of medical devices in Australia and improve health outcomes for patients who require medical devices. As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates therapeutic goods, and is responsible for implementing the Government’s reforms. The TGA conducted this consultation as part of the reform program.
This is the second TGA consultation published relating to the proposed Australian implementation of a Unique Device Identification (UDI) System for medical devices. It builds on the first consultation paper, Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia, The potential implementation of a UDI System in Australia is a significant undertaking, involving a broad range of stakeholders, changes to business processes and IT systems, and with a significant level of complexity; particularly around the areas of labelling, provision of data, transition periods, and the management of legacy devices.
Whilst acknowledging the benefits of a globally aligned UDI System, there is the need to consider characteristics unique to the Australian environment. Some of those characteristics include potential linkages between the AusUDID and the ARTG, and the number of manufacturers who supply devices across Australia and other international markets, who may be required to be compliant with other jurisdictions’ regulations (the European Union (EU) and United States Food and Drug Administration (U.S. FDA) requirements in particular).
The Consumers Health Forum of Australia (CHF) is the national peak body representing the interests of Australian healthcare consumers and those with an interest in health consumer affairs, including health-based research. We have over 250 members reflecting a broad spectrum of organisations including state-based consumer peaks, condition-specific groups, volunteer patient groups, professional associations, Primary Health Networks (PHNs) and the research community.
We work in collaboration with our members, national partners and research collaborators to influence policy, programs and services to ensure they are in the consumer and community interest. CHF is pleased to make this submission in response to this TGA Consultation on enhancing medical device adverse event reporting.
Note that this consultation was administered as an online survey and this document has been adapted from the CHF submission to that survey.