Closes 2 October 2026

TGA Consultation | Sharing More Information About the Safety, Quality and Performance of Medical Devices

Description

The Therapeutic Goods Administration (TGA) is inviting feedback on a proposed initiative to increase the amount of information shared with the public about the safety, quality and performance of medical devices.

The consultation seeks views on whether information should be publicly shared when a medical device is subject to a post-market review or investigation, and what types of information would be most useful during these processes.

The proposal aims to improve transparency and provide greater access to information about medical devices, particularly where review findings relate to the safety, quality, performance or use of a device.

The proposed changes align with the objectives of the TGA’s Action Plan for Medical Devices and support requirements outlined in the World Health Organization’s (WHO) Global Benchmarking Framework.

The consultation specifically seeks feedback on:

• Whether information about medical devices involved in a post-market review or investigation should be shared publicly.
• What types of information should be made available while a post-market review or investigation is underway.

The consultation paper and submission form are available through the TGA Consultation Hub. The survey takes approximately 15 minutes to read and complete.