FDA allows several QA systems to qualify companies to offer items for sale (as long as you have a bona fide QA system that is audited and follows their requirements). Canada, on the other hand, made the MDSAP system the only system that is accepted for medical devices for sale in Canada. While the FDA will accept the MDSAP system, Canada only accepts the MDSAP system. It went into effect in January of this year.
Because of this, many manufacturers and distributors have elected to withdraw from the Canadian market , primarily due to the increased costs associated with performing the MDSAP. One way around it is to have a company who is currently registered in MDSAP take on your product under their system. Of course this is an added layer to the supply chain that increases costs all around. Somehow, Health Canada sees these added costs with reduced access to medical products as a benefit to the public, despite no guarantee that they can demonstrate validation and verification of efficacy (like we are expected to provide for our actions). I apologize for my crankiness.