In Australia, medical devices are regulated under the Therapeutic Goods Act (1989) and the Medical Devices Regulations (2002), by the Therapeutic Goods Administration. The framework has adapted to facilitate effective, risk-based regulation of innovative medical devices, including software and "custom-made" devices. Whilst being based on principles (the Essential Principals), the Regulations have rules that determine the degree of regulatory oversight and specific points that need to be addressed for categories of devices.