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Consultation: Proposed enhancements to adverse event reporting for medical devices

5 July 2021

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.

Stakeholders were invited to review the consultation paper and provide a response using an online survey, both of which were accessible through our Consultation Hub. The consultation included two versions of the survey - one for industry and one for consumers. The questions posed in the survey relate to the same proposal but are viewed through a different lens.

A summary of industry responses and individual consumer responses to the survey have been published on the Consultation Hub.

Next steps

The survey findings indicate that follow-up discussions should occur on some of the proposed options. This feedback will be provided to the Minister for Health and as appropriate, inform Australian Government policy and regulatory drafting decisions. The TGA will continue to work closely with stakeholders, including scheduling further targeted discussions, specifically seeking additional feedback from consumers, consumer representative groups, health professionals and healthcare services.

Events: The TGA held three webinars to provide targeted information to the medical devices Industry and consumers about the proposed enhancements to adverse event reporting:

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