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:
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.