This consultation closed on Wednesday, 10 February 2021.
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. We issued this consultation paper as part of the reform program.
The definition of the Central Circulatory System (CCS) within the Australian medical device framework is reflected in the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations), which was established from 2002. In developing the Regulations in the early 2000s, a risk-based approach was taken to include the common iliac arteries in the definition of the CCS.
This consultation invited respondents to provide feedback on whether to amend the definition of the CCS within the Australian medical device framework. For more information on this consultation, including its outcomes, visit our consultation hub.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.