ABSTRACT
The regulation of medical devices in the Commonwealth of Australia dates from 1966, when the Australian Parliament passed the Therapeutic Goods Act 1966. This act placed responsibility for control of therapeutic goods under the Therapeutic Goods Administration (TGA) within the Australian Department of Health and Aging (DOHA).* On February 15, 1991, the Therapeutic Goods Act 1966 was superceded by the Therapeutic Goods Act 1989.** The Therapeutic Goods Act 1989 placed additional controls on medical devices (called therapeutic devices in the act) that are perceived to present a significant risk to the patient or user.
