Australia lines up with Europe - harmonisation several steps closer in 1996
This article was originally published in Clinica
Executive Summary
Substantial progress towards harmonising Australia's device regulations with the European system was made during 1996. The mutual recognition agreement between Australia and the EU was initialled and the government sent out for comment a proposal to transpose the medical device directives directly into Australian law. If Australia opts to take this route, substantial changes to existing legislation will be needed.