TGA Lays out 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.

The deadline for compliance to the new standard is January 2019.