TGA News Issue 53 (July 2007)
Australia-Canada medical devices MoU
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.
Medical devices October 2007 transition update
The Therapeutic Goods Amendment Bill was introduced into the Australian Parliament on 20 June 2007. The amendments provided for in this Bill substitute the existing requirement within subsection 9B(2) of the Therapeutic Goods Act 1989 (the Act) for therapeutic device sponsors to have their products entered in the Australian Register of Therapeutic Goods (ARTG) as "included" medical devices by 4 October 2007 with the requirement to lodge an effective application for either TGA conformity assessment certification or for inclusion in the ARTG by 4 October 2007.
The effect of the amendment, if passed, will create certainty of supply of product for those sponsors who have submitted an effective application before 4 October 2007.
An application is effective only if it is:
- made using the appropriate form; and
- submitted to the TGA; and
- accompanied by the prescribed fee; and
- contains all the necessary certifications, where required; and
- does not contain information that is false or misleading in a material particular.
Registered and listed products for which there is no effective application will be taken to be cancelled on 4 October 2007 and any supply (importation, manufacture, sale or exportation) of these products after 4 October 2007 will be in breach of the Act.
Further information on the requirement to transition product is available: Important advice regarding listed and registered devices.