Australia’s Therapeutic Goods Administration reached the end of its three-year transition period to the 2016 version of ISO 13485 and devicemakers using the updated standard to show Quality Management System (QMS) conformity are now expected to have their systems up-to-date.
As of March 1, all ISO 13485:2003 certificates issued by the TGA are now expired and may not be extended. Only 2016 QMS certificates can now be issued by the agency to manufacturers who have been audited according to the new standard.
The agency said manufacturers must provide evidence in their conformity assessment applications that their QMS has been implemented in harmony with ISO 13485:2016.
