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The Australian Medical Device Vigilance System
Derrick R. Beech
25 - 28
10.3233/978-1-60750-872-4-25
Studies in Health Technology and Informatics
Volume 28: Information Exchange for Medical Devices
Abstract

Since its inception, in 1986, the Australian Vigilance System has had voluntary and compulsory components. The voluntary component is the Therapeutic Device Problem Reporting Scheme and the compulsory one is requirements on sponsors to report as a condition of entry on the Australian Register of Therapeutic Goods. In addition, reports produced worldwide are actively monitored for their applicability to Australia.

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