We have just submitted our application for regulatory approval in Australia!
Our acting CEO Andrew Park noted
“seeking approval in Australia as a class III medical device represents a six-figure investment, but it is very satisfying one for the company. Our clinical studies were conducted there and taking the benefits of Chitogel to their wider population has always been a goal. Along with our pending European CE mark, these submissions have been a lot of hard work for the team, but they represent a large platform for the next stage of our growth”
What is the TGA?
The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health, and is responsible for regulating therapeutic goods including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products.
Almost any product for which therapeutic claims are made must be entered in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia.
