Canadian market access

Canadian Medical Device Regulations (CMDR) and ISO 13485

Canada market accessFor manufactures who wish to sell Class II, III, and IV medical devices, Health Canada requires you 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.