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Medical Devices: Reclassification framework of certain devices

Posted on December 8, 2021

As of the 25th November 2021, the Therapeutic Goods Administration (TGA) has commenced the implementation of revised medical device framework incorporating reclassifications for some medical devices.  The medical device framework includes new regulatory requirements, to demonstrate the safety and efficacy of products commensurate with the higher classifications.

Sponsors with:

  • Spinal implantable devices;
  • Active devices for therapy with a diagnostic function;
  • Devices composed of substances introduced into the human body via an orifice;
  • Devices that administer via inhalation; and
  • Devices intended for short-term use in direct contact with the heart

are impacted by the reclassifications and will be required to follow the transitional arrangements to ensure they are in compliance with these new regulations.

Manufacturers and Sponsors of affected devices already included in the ARTG are required to notify the TGA by May 25th 2022, and submit a new ARTG application by November 1st 2024. 

We encourage all potential suppliers and manufacturers to consult the published guidance to seek up to date information and ensure the supply and manufacture of devices is compliant with these requirements.

Navigating the regulatory requirements can be complex. If you are looking to introduce or continue the supply of these devices and require support, please contact our experienced team at [email protected].