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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