Signing of the Memorandum of Understanding (MoU) on the quality management system certification for medical devices between the Therapeutic Goods Administration (TGA) and the Health Products and Food Branch (HPFB) Health Canada
18 June 2007
On 1 June 2007 the Parliamentary Secretary to the Minister for Health and Ageing, Senator Brett Mason, and the High Commissioner for Canada, His Excellency Mr Michael Leir, signed a Memorandum of Understanding (MoU) on Quality Management System Certification for Medical Devices. The MoU is a culmination of work done by both the TGA and Health Products and Food Branch (HPFB) - Health Canada since 2004 and is an important arrangement that will enhance regulatory cooperation between the two regulatory bodies.
The MoU establishes an arrangement where upon completion of the Confidence Building Exercise, it will enable Australian and New Zealand manufacturers of medical devices to export their products to Canada and Canadian manufacturers of medical devices to export their products to Australia and New Zealand without needing to undergo duplicate assessments of their quality management systems.
This MoU is significant to both Australian and New Zealand manufacturers of medical devices and is expected to be fully operational under the Australia New Zealand Therapeutic Products Authority.
Left: His Excellency Mr Michael Leir, High Commissioner for Canada
Middle (on screen): Mr Neil Yates, Assistant Deputy Minister, Health Products Food Branch, Health Canada
Right: Senator the Hon. Brett Mason, Parliamentary Secretary to the Minister for Health and Ageing.