Overhaul for medical devices in Australia

9 April 2019

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

The plan aims to improve transparency and ensure manufacturers provide more information about their devices. This will influence the marketing authorisation process for new devices and the follow-up of existing devices. Open public consultations will be held to gain feedback on specific proposals.

“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,” said the TGA. “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 those defied as software as a medical device (SaMD). The TGA will update the assessment process to address cybersecurity risks and provide guidance on associated requirements for IT systems.

The regulator wants to identify problems with existing devices and enable quicker action to be taken. These systems will facilitate cross-checks with international regulators regarding any significant adverse events reports on specific products. The traceability of devices across the healthcare supply chain will be prioritised, which includes the proposal of a device identifier system to track product history. The regulator will publicly report review timeframes for new products to help ensure faster access to consumers.



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