Based on the answers you have given, your product may be regulated as a blood or blood component. You can find out more about the way TGA regulates blood and blood components on the blood and blood components webpage.
Overview
Blood, blood components are regulated by the TGA. Under the Therapeutic Goods Act 1989, 'blood' means whole blood extracted from human donors and 'blood components' means therapeutic components that have been manufactured from blood (including red cells, white cells, progenitor cells, platelets and plasma). 'Blood components' does not include products derived through the fractionation of plasma (which are biological medicines).
Some blood and blood components are exempt from TGA oversight and can be found on the regulation of blood webpage.
Useful links
If you are new to therapeutic goods regulation you should also familiarise yourself with: