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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 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