Australia Considers Allowing Devices Approved Overseas to be Marketed

Australia Therapeutic Goods Administration is considering a proposal to allow devices that have received marketing approval overseas to be marketed in Australia. This use of comparable overseas approvals as evidence of regulatory compliance may avoid the need for duplicate assessments.  Currently, it is anticipated that only those participating in the International Medical Device Regulators Forum would be evaluated, but it is possible for other regulators to be evaluated on an application by application basis.

European Union notified bodies support more than 90% of the existing submissions, but there are differences between the Australian and EU device requirements (such as device classification) that need addressing prior to enactment.

There are several criteria currently being assessed as part of this process such as the gap between overseas approval and additional information required by the Therapeutic Goods Administration to establish compliance and whether the overseas regulator takes into account the same or similar regulatory objectives that are prescribed in Australia’s legislation and regulations.  Australia is also considering whether the regulatory framework of overseas regulators applies across the whole life cycle of a device and the approach for postmarket surveillance. Quality management system assessments and potential differences in approach will also be evaluated.

The Therapeutic Good Administration is aiming to have legislation regarding this topic take effect in January 2018.