Registering a medical device in Australia is a complex but crucial process that ensures the safety and performance of devices entering the healthcare market. Navigating the regulatory landscape of the Therapeutic Goods Administration (TGA) can be daunting, particularly for new manufacturers and innovators.

The long-awaited transition to the EU Medical Devices Regulation (MDR) is looming. The regulatory realm of medical devices is in a state of flux and poised on the brink of the most significant change to the landscape in decades. Despite the postponement of the EU Medical Devices Regulation’s implementation to May 2021 appearing to offer