TGA Reveals Medical Device Action Plan

Australia’s Therapeutic Goods Administration has unveiled a plan to reform device regulations, improve patient safety and better inform consumers.

The three-part initiative looks to reform the way devices get approved for Australian marketing, strengthen the monitoring of already-approved devices, and give patients more information about devices they use. One focal point of the plan is to bring more transparency to the agency and increase device oversight.

Australia’s regulatory requirements “are some of the most stringent in the world,” but more can be done to strengthen the system, TGA said.