Delays to medical device regulatory changes and reforms

MedTech News: Reflecting the challenges identified by the medical devices industry and healthcare professionals as they have focused on the COVID-19 crisis, the Australian Government intends asking the Governor-General in Council to agree to the proposed delay of the commencement of a number of medical device reforms.

The delay would also support additional time for the Therapeutic Goods Administration (the TGA) to consult with the medical device industry and health care professionals on guidance material relating to the reforms.

The Australian Medical Device Regulations would be 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

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

Essential Principles

Amendments to the Essential Principles in the Australian Medical Device Regulations and their implementation are also proposed to be 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 would provide 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.