Access to the Australia and New Zealand markets
Certification according to the regulations in Australia and New Zealand
Mutual recognition with Australia and New Zealand
Under mutual recognition agreements signed in 1998 by the European Union with Australia and New Zealand, manufacturers have the possibility to ask for a MRA certificate to LNE/G-MED who is a designated body in the framework of these agreements (EU CAB).
The scope of the agreements largely corresponds to the medical device categories covered by Directives 90/385/EEC and 93/42/EEC. Excluded are radioactive products, in vitro diagnostic devices, devices utilizing tissues of animal origin, devices incorporating medication and devices presenting particular risks.
The manufacturer must register his products in the Australian Register of Therapeutic Goods (ARTG), or in New Zealand’s WAND database (Web-Assisted Notification of Devices), before placing them on the market.
Useful links
Overview of the medical device regulatory process
Agreement on mutual recognition in relation to conformity assessments, certificates and marking
Australia - European community mutual recognition agreement (EC-MRA)