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Consultation: Proposed enhancements to adverse event reporting for medical devices

18 November 2020

This consultation closed on 2 December 2020.

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 as part of the reform program.

This consultation paper relates to the proposed enhancements to adverse event reporting and improving communication with the consumers of medical devices. We invite you to review the consultation paper and provide a response using online survey, both of which are accessible through our Consultation Hub. This consultation includes two versions of the survey - one for industry and one for consumers. The questions that are posed in the survey relate to the same proposal but are viewed through a different lens.

Events: The TGA has organised three webinars that aims to provide targeted information to medical devices Industry and consumers about the proposed enhancements to adverse event reporting.

  • Webinar 1 - 19 October 2020, 11:00-11:30am
    • Invitee: Industry
    • Discussing proposal: 1, 2, 4 and 5
  • Webinar 2 - 26 October 2020, 2:00-2:45pm
    • Invitee: Consumers
    • Discussing proposal: 1, 2, 4 and 5
  • Webinar 3 - 2 November 2020, 2:00-2:45pm
    • Invitee: Industry and Consumers
    • Discussing proposal: 3

We appreciate all views, so if you would prefer to respond by email or written document, you can find further details on the hub.