Australia and Canada today signed a Memorandum of Understanding (MoU) recognising each other’s assessments of new medical devices.
1 June 2007
BM 17/07
The Parliamentary Secretary to the Minister for Health and Ageing, Senator Brett Mason, and the High Commissioner for Canada, Mr Michael Leir, signed the MoU on Quality Management System Certification for Medical Devices. It follows the signing of a Mutual Recognition Agreement (MRA) between Australia and Canada in May 2004 that enables each country to accept the other’s Good Manufacturing Practice (GMP) audits and inspection of the makers of prescription and over-the-counter medicines.
The MoU will enable Health Canada to recognise Quality Management System certifications issued by Australia’s Therapeutic Goods Administration (TGA) for Australian and New Zealand manufacturers exporting to Canada, and for the TGA to recognise QMS certifications issued by Canadian Registrars (auditing bodies) for Canadian manufacturers exporting to Australia and New Zealand.
“Both TGA and Health Canada have strong regulatory programs and share the common goal of protecting the health and safety of their populations,” Senator Mason said.
“Agreements such as this help to streamline approval processes for sorely needed new medical devices, leading to better treatments and better health outcomes for our people.”
“This memorandum has been made possible through the concerted efforts of officials in both organisations and a strong commitment to a shared goal: facilitating timely access to each other’s markets and to new technologies by reducing the regulatory burden and duplication, while maintaining high regulatory standards,” Mr Leir said.
The signing marks the start of the final, enabling phase of the process, after which the MoU will become operational. This phase, which will include observed audits of medical device manufacturers, will be completed by the end of the year.
From that time QMS certificates issued by the TGA will be recognised by Health Canada and taken into consideration when application is made for a device licence to allow supply in Canada. Likewise, the TGA will recognise QMS certifications issued by a participating Canadian Registrar, and take them into consideration when applications are made for a TGA-issued Conformity Assessment Certificate. Subsequently, an Australian company may apply for inclusion in the Australian Register of Therapeutic Goods to allow supply in Australia.
Media contacts: Carolyn Martin (Senator Mason’s office) 0417 966 328
Canadian High Commission: Inge Rumble 6270 4022
