Australia to reform medical device regulatory system

5 April 2019 (Last Updated April 5th, 2019 11:15)

The Australian Therapeutic Goods Administration (TGA) has announced plans to overhaul the regulatory system for medical devices in the country to increase patient safety.

Australia to reform medical device regulatory system
An action plan published by TGA aims to improve transparency on medical devices. Credit: Mauro Cateb.

The Australian Therapeutic Goods Administration (TGA) has announced plans to overhaul the regulatory system for medical devices in the country to increase patient safety.

An action plan aims to improve transparency and ensure manufacturers provide more information about their devices to patients and healthcare professionals.

The plan will improve the marketing authorisation process for new devices and the follow-up of existing devices.

Open public consultations will be conducted to obtain feedback on proposed policies, regulations and guidance materials.

“Involving consumers in the process is critical, noting that decisions on new policies or changes to the Therapeutic Goods Act will be required from Parliament.”

Announcing the action plan, the TGA said: “It will fast track TGA’s implementation of medical device reforms already underway and consult on new ways to improve transparency and increase public and health professional confidence in the regulatory system.

“Involving consumers in the process is critical, noting that decisions on new policies or changes to the Therapeutic Goods Act will be required from Parliament prior to potential implementation.”

Under the new plan, regulations will be expanded to cover technologies such as 3D printed devices and software apps. The TGA will update the assessment process to address device cybersecurity risks and offer guidance on associated requirements for IT systems.

The regulator intends to identify problems with existing medical devices and enable quicker action. These systems will facilitate cross-checks with international regulators regarding any significant adverse events (AE) reports on specific products.

TGA will prioritise the traceability of devices across the healthcare supply chain. It plans to propose a device identifier system to track product history.

Following media reports about unsafe medical devices, TGA plans to team up with consumer groups to co-develop a strategy that would promote awareness about the regulatory system.

TGA said: “We will also strengthen consumer awareness of the responsibilities of the TGA, suppliers of medical devices and health professionals through a range of new consumer communication and education programmes.”

The regulator will publicly report review timeframes for new products to ensure timely access to consumers.