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What you need to know?


The following give you an idea on what you may wish to consider prior to starting the journey of Device inclusions on the ARTG:


  • Is the device currently on the ARTG?
  • If you are considering importation of a device you need to be an Australian resident.
  • All devices imported into Australia must be included on the ARTG prior to distribution and use on any person.
  • The TGA is a regulatory system and you will pay fees to included devices on the ARTG.
  • You need to have a clear understanding from your manufacturer do they have the correct certification required to satisfy the TGA.
  • How much are you prepared to spend.
  • Do you have arrangements in place for supply of a device.
  • Have you considered the implications of insurances and handling costs.
  • How long do you wish to supply a device in Australia and New Zealand.
  • Do you have support form the manufacturer with respect to quality and efficacy.
  • Do you understand the essential principals of the device to be supplied.
  • Are you buying  the devices from a quality manufacturer?