Consultation: Australian Medical Device Regulations definition of Central Circulatory System (CCS)

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.

In 2019, the TGA consulted on changes to the classification rules in Proposed changes to the classification of medical devices used in direct contact with the heart, central circulatory system and central nervous system. Feedback from this suggested that further consultation in relation to the definition of CCS would be beneficial.

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.