3.0 Regulatory Requirements for Medical Technology Course
Regulatory Requirements for medical technology in Australia are similar to those adopted in the European Union. However, there are differences.
The Therapeutic Goods Administration (TGA) regulates the supply of therapeutic goods in Australia. Before a sponsor can supply a medical device, the manufacturer must apply an appropriate conformity assessment procedure, and the sponsor must arrange for the devices to be entered in the Australian Register of Therapeutic Goods (ARTG). The Regulatory Requirement for Medical Technology course consists of a series of modules designed to assist regulatory and quality professionals.