Consultation: Improved sharing of information about medical devices | Proposed amendments relating to transparency of disruptions to supply of a medical device

Overview

We want your feedback on the proposed changes to improve transparency about disruptions to the supply of medical devices.

The proposed changes are intended to help in monitoring, assessing and responding to potential and actual supply disruptions.

These changes align with the intent of An Action Plan for Medical Devices to provide more information to patients about the medical devices they use.

What this consultation is about

The consultation outlines proposed changes that would allow the TGA to more effectively release certain information about actual or potential disruptions to the supply of a medical device.

Your feedback is sought on:

• whether the TGA should release information about managing medical devices shortages or disruptions to supply
• whether the information should be made public or shared only to specific stakeholders
• what types of information should be released when a medical device supply disruption occurs
• whether sponsors should be notified and given the opportunity to comment before information is released

Why your views matter

Your feedback will help inform advice to the Australian Government regarding any proposed changes to the medical devices regulatory framework. In addition to the scope of the consultation, we welcome your feedback on the consultation process.

You can review the consultation on our consultation hub and submit your feedback by using our online survey tool or email your response to devicereforms@tga.gov.au.