Medical devices reforms

The Medical Devices Reforms aim to enhance the safety, performance and quality of medical devices in Australia and focus on patient safety.

About the Reforms

The Australian Government is undertaking a significant program of reforms to strengthen the regulation of medical devices in Australia.

For more information see:

• Medical device reforms: Regulatory changes
• Delays to the commencement of certain medical device regulatory changes.

An Action Plan

An Action Plan for Medical Devices provides an overview of the reforms grouped under three strategies.

Strategy 1: Improve how new devices get on the market

• Implementation of a priority review pathway for medical devices
• Establishment of Australian Conformity Assessment Bodies
• Reviewing the regulation of low risk products
  • Class 1 medical devices
  • Other therapeutic goods
• Changes to the regulation of Personalised Medical Devices (PMD)
• Point-of-care manufacturing of medical devices
• Reviewing the regulation of self-testing IVDs
• Changes to the regulation of IVD Companion diagnostics
• Changes to the regulation of medical device software (including SaMD)
  • Re-classification of software based medical devices
• Reclassification of certain medical devices
  • Reclassification of spinal implantable medical devices – guidance on the transitional arrangements and obligations
  • Reclassification of devices used in direct contact with the heart, central circulatory system (CCS), or central nervous system (CNS)
  • Reclassification of medical devices that are substances introduced into the body via body orifice or applied to the skin
  • Reclassification of active implantable medical devices (AIMD)
  • Reclassification of medical devices that administer medicines or biologicals by inhalation
  • Reclassification of active medical devices for therapy with a diagnostic function
  • Outcomes of reclassification of a number of medical devices following consultations in 2019
  • Frequently asked questions (FAQs) on reclassification of medical devices
• Benchmarking against international assessment timeframes
• Mutual Recognition Agreement (MRA) changes
• Acceptance of comparable overseas regulator approvals in Australia

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

• Reclassification of surgical mesh devices 
  • Reclassification of surgical mesh medical devices
  • Information for medical practitioners on up-classification of surgical mesh devices
  • Reclassification of surgical mesh
• Establishment of a Unique Device Identification System
• Enhancements to post-market monitoring
  • Progress update: Improving post-market monitoring and surveillance of medical devices
  • Progress update: Mandatory reporting of adverse events by healthcare facilities

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

• Implementation of consumer/patient information materials requirements
• Instructions For Use (IFU) for medical devices
• Reporting the TGA’s assessment timeframes publicly
• Consumer representation on the TGA’s expert working groups
• Establishing the Medical Devices Consumer Working Group
• Establishing the Women’s Health Products Working Group
• Five questions to ask your health professional before you get a medical implant
• Improving consumer/patient information