Australian medical device regulations: An overview

Abstract

In Australia, medical devices are regulated by the Therapeutic Goods Administration (TGA). The Australian medical device regulatory requirements, which were implemented in 2002, are largely based on the European Council Medical Device Directive (MDD) 93/42/ European Economic Community (EEC). The body responsible for regulating medical devices in Australia is the Office of Devices Authorisation, within the TGA. The TGA is a division of the Australian Government Department of Health and Ageing. All regulatory decisions applicable to medical devices are made using legislation as set out in the Therapeutic Goods Act 1989, Therapeutic Goods Regulations 1990, and the Therapeutic Goods Regulations 2002. Medical devices are classified on the basis of risk, through consideration of the manufacturer's intended use, degree of invasiveness in the human body, and duration of use. The majority of medical devices must be included in the Australian Register of Therapeutic Goods (ARTG) before being made available for supply in Australia.