Medical devices reforms: An Action Plan for Medical Devices

An Action Plan for Medical Devices (Action Plan), was released on 4 April 2019.

It includes 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.

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.