TGA Maps Transition to ISO Quality Management Standard

Australia’s Therapeutic Goods Administration will transition to the ISO 13485:2016 standard governing medical device quality management systems over the next three years.

The agency clarified that the 2003 standard and the 2016 standard will co-exist during the three-year transition period.

Users of ISO 13485:2003 should work with the TGA or their EU Notified Body or the Medical Devices Single Audit Program organization to schedule an upgrade audit during the transition period. — Tamra Sami