Medical device reclassification in Australia

As Australia’s Therapeutic Goods Organisation (TGA) continues to harmonise its medical device legislation with those being implemented in the European Union (EU), the agency has provided the latest information on its reclassification of certain devices.

Six categories of device have been reclassified:

  • Spinal implantable medical devices
  • Active medical devices for therapy with diagnostic function
  • Active implantable medical devices and their accessories
  • Medical devices that administer medicines or biologicals by inhalation
  • Medical devices that consist of substances introduced into the body via a body orifice or applied to the skin
  • Medical devices used in direct contact with the heart, central circulatory or central nervous systems.

In addition, five draft guidance documents on the reclassification of devices have been provided to the Regulatory and Technical Consultative Forum for medical devices in June 2020 for feedback. This will inform the final guidance documents which will be published alongside guidance on transitional arrangements for devices that are currently included in the Australian Register of Therapeutic Goods (ARTG).

Due to issues raised in submissions, the TGA will continue to consult on the proposed classifications for storage solutions for human cells, tissues and organs, and IVF media prior to implementing any regulatory amendments for this category of devices.

For more information, click here.