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

11 January 2021

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 have issued this consultation paper as part of the reform program.

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 Central Circulatory System (CCS) would be beneficial.

The definition of the CCS within the Australian medical device framework is reflected in the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations), and 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. Taking into account new and existing feedback from previous consultations, the TGA is reviewing the Australian definition of the CCS and is requesting further feedback in relation to this definition, to determine whether any changes should be made.

We invite you to review the consultation paper and provide a response using our online survey, both of which are accessible through our consultation hub. We appreciate all views, so if you would prefer to respond by email or written document, you can find further details on the hub.