title: The Australian Medical Device Vigilance System.
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.
authors.affiliation: Therapeutic Devices Branch, Therapeutic Goods Administration, Woden, Australia.
authors.forename: D R
authors.initials: DR
authors.lastname: Beech
mesh_terms: D001315:Australia; D004869:Equipment Safety; D004864:Equipment and Supplies; D005062:European Union; D017408:Guidelines as Topic; D011358:Product Surveillance, Postmarketing / Q000379:methods