Translate This Page

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 permanent resident or citizen.
  • All devices imported into Australia must be included on the ARTG prior to distribution and importation.
  • 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.
  • Please also consider the use of an MDSAP; You will need to supply either Canadian or FDA certification documentation.
  • What is your regulatory budge?
  • Do you have arrangements in place for supply of a device? Do you have a contract of supply wish your distributor in Australia?
  • 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?
  • Do you have a supply contract in place?
  • What are you long term goals for supplying a device in Australia and New Zealand