Australia – Medical device regulation changes

Changes have been made to the regulation of:

  • software-based medical devices
  • prescription spectacle lenses
  • medical devices containing microbial, recombinant, or animal substances
  • medical device application audit requirements.

The changes came into effect on 15 June 2024 for:

  • software-based medical devices
  • prescription spectacle lenses.

The changes will come into effect on 1 July 2024 for:

  • medical devices containing microbial, recombinant, or animal substances
  • medical device application audit requirements…