Medical devices reforms: An Action Plan for Medical Devices

An Action Plan for Medical Devices (Action Plan), released on 4 April 2019, is a three-part strategy to strengthen Australia's regulatory system, whilst continuing to be patient focused and have greater transparency, and increase public confidence in Australia's medical device regulatory system.

The three strategies outlined in the Action Plan are:

Strategy 1: Improve how new devices get on the market

• more rigour in assessment processes
• more reviews of low and medium risk devices
• higher level scrutiny of clinical evidence
• ensure new and emerging technologies are safe.

Strategy 2: Strengthen monitoring and follow-up of devices already in use

• scope the introduction of unique device identifiers
• enhance inspections and reviews to confirm ongoing quality and safety
• explore removing reporting barriers including potential of mandatory reporting of adverse events by healthcare facilities
• greater data analysis, information sharing and joined up systems with hospitals.

Strategy 3: Provide more information to patients about the devices they use

• publish more information about decisions made and the medical device products regulated by the TGA
• strengthen consumer awareness of how safety and performance of medical devices are assessed
• find and implement ways to help consumers report adverse events more easily
• establish expert groups with consumer representation.

The TGA published Progress Report Cards for the Action Plan for Medical Devices as updates on the progress made against Action Plan strategies to 31 December 2022:

• Progress Report Card: December 2022 
• Progress Report Card: September 2021 
•  Progress Report Card: June 2021
• Progress Report Card: April 2020

For more information on the specific Reform initiatives, visit Medical devices reforms.