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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.
Read more about the regulatory changes.
An Action Plan
An Action Plan for Medical Devices provides an overview of the reforms grouped under three strategies.
Read more about the Action Plan.
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)
- 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
- 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
- Reviews of devices of concern
- Establishment of a Unique Device Identification System
- Enhancements to post-market monitoring
Strategy 3: Provide more information to patients about the devices they use
Consumer information
The Medical Device Consumer Working Group works closely with the TGA, guiding and providing feedback into the Reforms as well as developing a range of consumer-focused products about medical devices.
This includes resources on surgical mesh, cyber security, cosmetic injections and breast implants, and the fact sheet Five questions to ask your health professional before you get a medical implant.
The Women’s Health Products Working Group was established as a commitment under the Medical Device Action Plan. The Group advises the Minister and the TGA on matters relating to the clinical evidence and policy matters about the safety, quality and efficacy or performance of medicines and medical devices. The considerations and outcomes from the working group will contribute to the objectives pursued under the National Women’s Health Strategy 2020-2030. Further information on this working group will be available soon.
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