Approval of Devyser’s RHD product in Canada
Devyser is today announcing that its product for non-invasive fetal RHD testing has been granted regulatory approval in Canada. Devyser already has a contract with Canada’s Héma-Québec to deliver RHD tests. The product approval by Health Canada means that it meets the established safety, efficacy and quality requirements for products marketed and sold in Canada. Devyser has had MDSAP approval for the quality management system since 2020, which is a requirement for product registration in Canada. The RHD test is Devyser’s first approved Class III IVD product in Canada. “