Public consultation | Sharing more information about medical devices

Overview

We want your feedback on our proposal to improve sharing information about the safety, quality and performance of medical devices.

This will take about 15 minutes to read and complete. 

The proposed changes intend to provide more information to the public after post-market reviews or investigations of medical devices, particularly where review findings relate to the safety, quality, performance or use of a medical device. 

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

What feedback do we want from you?

We will outline how the proposed changes would help us share more information with the public about medical devices. 

You can help us with feedback on:

• if we should share information about medical devices involved in a post-market review or investigation, and 
• what types of information should be shared when a post-market review or investigation is being undertaken.

Background

In 2019, we released An Action Plan for Medical Devices (Action Plan), a 3-part strategy designed to strengthen Australia’s regulatory framework for medical devices (including in vitro diagnostics). The plan emphasises the need for a patient-centred approach and increasing public confidence in the regulation of medical devices through greater transparency.

Transparency of information has been recently outlined in the World Health Organization's (WHO)  Global Benchmarking framework. The framework is intended to:

• strengthen regulatory systems globally so that medical devices are safe, effective, and of assured quality, both before and after they reach the market,
• enable regulatory reliance between countries, and
• provide the Global Benchmarking Assessment that requires that national regulators have robust mechanisms for communicating and being transparent with healthcare professionals and the public. 

Section 61 of the Therapeutic Goods Act 1989 (the Act) facilitates the release of information in certain circumstances. This consultation seeks feedback on proposals to make amendments to the legislation to allow us to share more information about medical devices, specifically:

• provide more information to the public following post-market reviews or investigations, particularly where findings relate to the safety, quality, performance or use of the device. 

We previously consulted separately on releasing information to support management of disruptions to the supply of medical devices. Outcomes have been published on the TGA Consultation Hub.

The problem

Due to current legislative constraints, the TGA experienced challenges sharing information during the COVID-19 pandemic about safety, quality or performance of certain medical devices. The TGA worked closely with sponsors, manufacturers and health authorities to share information where possible to support the pandemic response in a timely way. These challenges with the legislative constraints still exist including where regulatory action has been undertaken. 

Currently the circumstances where we can release information to external stakeholders that are not the manufacturer or the sponsor of the medical device are limited and generally information cannot be shared unless:

• a legislative instrument has been made specifying the information that can be shared, or
• a regulatory decision about a specific medical device has been made, or 
• the information is required to facilitate the safe use of a medical device.

Sharing more information about medical device safety, quality and performance would enhance our existing ability to protect public health and safety. 

Where medical devices are investigated and there is no action required or the medical devices are compliant, we think this information should be shared with the public. This would improve transparency for consumers and foster trust with the regulatory system. This would also reduce administrative burden for consumers and manufacturers/sponsors, as information would not need to be sought when publicly available. 

The above is a short summary of the consultation paper. For further detail, the full paper can be viewed in the related content below. 

Why your views matter

Your feedback will inform advice to the Australian Government regarding any proposed changes to the medical device regulatory framework. We also welcome feedback on your experience with the consultation process.

If you have any difficulties using the online survey tool and are unable to submit your response online, please email devicereforms@tga.gov.au for assistance.