Medical device reforms

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

For details go to:

• Medical devices reforms

• Medical device reforms: Regulatory changes

• Australian Government Response to the Review of Medicines and Medical Devices Regulation

Action plan

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

Read more about An Action Plan for Medical Devices.

Key information

• MMDR: Medical devices regulatory reforms
• Medical devices reforms: priority review pathway
• MMDR: Accessing unapproved products reforms
• MMDR: TGA advisory committees reforms
• Delays to the commencement of certain medical device regulatory changes

Reclassification

• Medical devices reforms: 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
• 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

Post-market

• Medical devices reforms: Enhancements to post-market monitoring
• Progress update: Improving post-market monitoring and surveillance of medical devices
• MMDR: Post-market monitoring reforms

International 

• Medical device reforms: Comparable overseas regulator marketing approvals
• Medical devices reforms: Mutual Recognition Agreements (MRA)
• Medical device reforms: Benchmarking against international assessment timeframes

Consumer/patient

• Medical device reforms: Establishment of a Unique Device Identification system
• Medical devices reforms: Consumer / patient information materials requirements

Surgical mesh

• Reclassification of surgical mesh devices
• Reclassification of surgical mesh medical devices
• Information for medical practitioners on up-classification of surgical mesh devices
• Medical devices reforms: Reclassification of surgical mesh

Personalised devices

• Regulation impact statement: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices
• Medical devices reforms: Personalised medical devices

Software

• Medical devices reforms: Medical device software regulation
• Re-classification of software based medical devices

Low risk products

• Medical devices reforms: Low risk products
• Medical devices reforms: Low risk products - Class 1 medical devices
• Medical devices reforms: Low risk products - other therapeutic goods

In-vitro diagnostic devices (IVDs)

• Medical devices reforms: IVD companion diagnostics
• Medical devices reforms: Review of the regulation of certain self-testing in vitro diagnostic medical devices (IVDs) in Australia

Conformity assessment

• Medical devices reforms: Conformity assessment bodies
• Conformity assessment certificates, changes to requirements for certain medical devices

Hip, knee and shoulder replacement joint replacements

• The reclassification of hip, knee and shoulder replacement joint replacements took place in 2012. Trove at the National Library has information on these reforms.