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
- 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)
- 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
- Establishment of a Unique Device Identification System
- Enhancements to post-market monitoring
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