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Medical Devices / Regulatory Affairs

Regulatory Reform Leads TGA’s Goals for 2018

Jan. 5, 2018

Australia’s Therapeutic Goods Administration will continue its overhaul of medical device regulations and engaging with global regulators as top priorities for the year ahead.

The Australian parliament passed a first phase of reforms last June, largely focused on assessment pathways, and a new expedited pathway for novel devices was made available on Jan. 1, 2018.

Expanded access to medical devices will also be available under new special access and authorized prescriber schemes. The enabling legislation calls for collecting more post-marketing safety data from sponsors to provide more information about products approved under expedited pathways.

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