MOU between the Canadian Health Products & Food Branch and the TGA for medical devices

2 March 2005

The Health Products and Food Branch (HPFB) of Health Canada and the Therapeutic Goods Administration (TGA), Department of Health and Ageing, Australia, met to work out the details on a Memorandum of Understanding (MOU) regarding the reciprocal recognition of quality system certificates issued for manufacturers of medical devices. The aim of this collaborative undertaking is to facilitate access to medical devices in each other's markets while maintaining high regulatory standards for these devices.

Towards this end, officials from the HPFB and the TGA met in Ottawa, Canada from 24 January to 4 February 2005 to develop and agree on the processes, procedures and framework required to achieve this objective. Good progress was made in this regard, and it is expected that the MOU will be in place prior to the commencement of the Australia and New Zealand Trans Tasman Therapeutic Products Agency in July 2006.

Further detail on the nature, scope and proposed implementation of the MOU and on plans to engage stakeholders will be communicated as the project progresses.