Australian Panel Urges New Pathways to Approve Medical Devices

June 26, 2015

A panel of experts is calling on the Australian government to establish three new approval pathways for medium- and high-risk medical devices and align with the EU regulatory framework to expedite listing on the Australian Register of Therapeutic Goods.

The recommendations, announced last week, are tied to the government’s plan to fast-track approvals of promising new medical technologies and conduct joint reviews with trusted foreign regulators — part of a broad effort to streamline the country’s device approval process.

The Department of Health and Ageing launched an independent review of the current framework last October (IDDM, Nov. 3, 2014).

The first pathway calls for a conformity assessment by the Therapeutic Goods Administration or an organization designated by the TGA. Specific criteria would be established for conformity assessment bodies, including the capacity to set requirements for medical device classes.

The second pathway focuses on devices from overseas markets and would allow for approval by another national regulatory authority or an organization designated by that NRA.

The panel recommends that the government develop criteria for identifying comparable overseas designating authorities and NRAs to evaluate devices in consultation with consumers, health professionals, devicemakers and the TGA.

Under this pathway, the TGA would still have to determine a medical device has been correctly classified, its marketing approval documentation is in order and it meets Australian requirements to be included on the ARTG.

The third pathway would allow for expedited approval. In these cases, the TGA would be able to place conditions on the device’s inclusion in the ARTG.

Additionally, the report recommends that Class 1 nonsterile and nonmeasuring devices continue to be included on the ARTG based on a self-assessment by the manufacturer.

The TGA should make clear to consumers and healthcare providers that while those devices are registered, they haven’t been subject to independent assessment, the panel says.

Read the panel’s report, Review of Medicines and Medical Devices Regulation, here: www.fdanews.com/06-25-15-australiareport.pdf.
— John Bechtel