On Oct 22, 2010 the TGA posted on their website the following info:
“The Therapeutic Goods Administration (TGA) and Health Canada (HC) are pleased to announce that the Memorandum of Understanding (MoU) on reciprocal recognition of quality management system (QMS) certificates for medical device manufacturers is now operational.
The implementation of the MoU will remove the need for duplicate assessments of the QMS of medical devices manufactured in Australia and Canada.
The MoU assists Australian manufacturers of medical devices in the export of products to Canada, and Canadian manufacturers of medical devices in the export of products to Australia.
With the MoU fully operational, QMS certificates issued by the Australian regulator, the TGA will be recognised by Health Canada, and taken into consideration as part of an application for a device licence that would allow supply in Canada.
Similarly, QMS certificates issued by a participating Canadian Registrar will be recognised by the TGA, and taken into consideration as part of an application for a Conformity Assessment Certificate issued by the TGA.
This reduction in regulatory requirements will serve to enhance regulatory cooperation between the TGA and HPFB, and facilitate timely access to new technologies.
The implementation of the reciprocal recognition agreement follows the completion of a rigorous confidence building exercise between the TGA and Health Canada’s Health Products and Foods Branch (HPFB). This exercise confirmed the comparability of the two regulatory systems in assessing a manufacturer’s quality systems.”
Also, there is a Fact Sheet that they issued the same day as the announcement of the program.