Consultation on the definition of Central Circulatory System (CCS) in the Australian Medical Device Regulations

Closed 10 Feb 2021

Opened 11 Jan 2021

Overview

The Australian Government is undertaking a significant program of reform to the regulation of therapeutic goods in Australia. 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.

Why we are consulting

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 undertaking to review the Australian definition of the CCS and is requesting further feedback in relation to this definition, to determine whether any changes should be made.

In this consultation we are seeking your views on:

  1. Do you have any feedback in relation to the risk classification of devices in contact with the common iliac artery and/or other blood vessels of the CCS?
  2. Are there any other issues relevant to the safety and performance of devices in contact with the common iliac artery?

For further background and information, please refer to the consultation paper Consultation on the definition of Central Circulatory System (CCS) in the Australian Medical Device Regulations, downloadable via a link at the bottom of this page.

We invite you to complete our online survey (click on the link below)

If you prefer, you can make a submission directly to the Department via post or email at the following addresses:

Medical Devices Reform Unit
Medical Devices Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606

devicereforms@tga.gov.au

If you choose to do this, you may download the MSWord version of the consultation paper to use as a template for your response. Please also download and complete a copy of the Cover Sheet. Both are available via links at the bottom of this page.

What happens next

Submissions will be reviewed by the TGA. A summary of responses will be published and all submissions will be placed on this website (unless marked confidential or indicated otherwise in the survey or submission form).

Outcomes from the consultation will be provided to the Government for consideration.

Audiences

  • Medical Devices & IVDs

Interests

  • Health technology