TGA releases proposal to recognise device approvals from select foreign authorities

On 22nd May, Australia’s Therapeutic Goods Administration (TGA) proposed a consultation to consider the use of devices that have received marketing approvals from those countries participating in the International Medical Device Regulators Forum (IMDRF).

Currently, EU Notified Bodies’ EC certificates support more than 90% of existing ARTG entries, however, the primary aim in releasing the proposal is to avoid duplicate assessments (by using approvals from other comparable overseas regulators as evidence of regulatory compliance) and to also be able to share the assessments with comparable regulators in an effort to advance applications submitted in parallel.

In order to achieve this safely, the TGA will need to consider differences between Australian and overseas regulatory requirements, the difference in the time when the device was assessed (as there can often be significant changes in a device if some time has elapsed between the overseas and Australian assessments) and post-market data including records of adverse events. This ‘mutual recognition’ will not necessarily guarantee approval by the TGA; the TGA emphasises that the different expectations regarding safety of medical devices in Australia and overseas will still exist and that may result in rejection of an application for pre-market approval of a device even though it has been approved overseas.

TGA expect regulatory amendments to be developed this year with the aim of them to take effect from 1 January 2018, depending on the outcome of the consultation.

The consultation will be open for comments until 30th June 2017.  To access the consultation, please click here.