Delays to the commencement of certain medical device regulatory changes

The Governor-General in Council has made regulations which delay the commencement of a number of medical device reforms in Australia. This delay reflects the challenges identified by the medical devices industry and healthcare professionals to redirect their efforts to regulatory changes as they have focussed on the COVID-19 crisis.

The delay will allow additional time for the Therapeutic Goods Administration (the TGA) to further consult with the medical device industry and health care professionals on guidance material and implementation details relating to the reforms.

The Australian Medical Device Regulations have been amended to delay implementation of the reforms from 25 August 2020 to:

• 25 November 2021 for reclassification of certain devices, including
  • spinal implantable medical devices
  • active implantable medical devices
  • medical devices that administer medicines or biologicals by inhalation
  • medical devices that are substances (or combinations of substances) for introduction into the body
  • active medical devices for therapy that include a diagnostic function to significantly determine patient management, and
  • medical devices that are intended to be used in direct contact with the heart, the central circulatory system or the central nervous system
• 25 February 2021 for medical device software
• 25 February 2021 for personalised medical devices (including 3D printed devices) and
• 25 November 2021 for systems or procedure packs.

It is important to note that the delay to the commencement of the reforms does not change the end of the transition period. This remains at 31 October 2024. This means there is now less time to transition to the new arrangement for these devices.

Essential Principles

Amendments to the Essential Principles in the Australian Medical Device Regulations and their implementation have been delayed for up to two years after the commencement of European Union Medical Device Regulation changes (i.e. May 2023) and IVD Medical Device Regulations - this is still to be confirmed by the European Parliament, but is likely to be May 2022, so two years after that date.

This provides time for industry to adjust to the EU regulations and to allow consideration of similar changes in the Australian context and ensure that the transition in Australia is implemented effectively.

Next steps

Further information about the reforms will continue to be published on the TGA's website, with the TGA also working closely with stakeholders to identify opportunities for continued consultation on guidance material over the coming months.

Contact us

Please contact the TGA at devicereforms@tga.gov.au should you have any queries or comments.