Australia-Canada Agreement Reduces Need for Duplicate QMS Assessments

Devicemakers doing business in Australia and Canada will have fewer quality assessments, thanks to an agreement between the countries to recognize each other’s quality management system (QMS) certificates. As part of the memorandum of understanding, QMS certificates issued by Australia’s Therapeutic Goods Administration can be used to apply for a device license in Canada and vice versa. The agreement also will facilitate device exports between the two countries by eliminating the need for a quality assessment in each country.
International Medical Device Regulatory Monitor