Gain market access in Canada with CMDR and ISO 13485 approval

Canadian Medical Device Regulations (CMDR) and ISO 13485

Canada-flagHealth Canada requires manufacturers who wish to sell Class II, III, and IV medical devices into Canada to provide an ISO 13485 quality system certificate, as evidence of compliance to the Canadian Medical Device Regulations (CMDR). This certificate can only be issued by a Canadian Medical Devices Conformity Assessment Scheme (CMDCAS) recognised registrar such as BSI.