Hello! Thanks, in advance, for any and all feedback! I am the Quality Manager of a US medical device company. We do not manufacture any devices. We purchase devices from manufacturers overseas and then facilitate the import of them into the US for distribution to customer sites. We do not store, handle or distribute any of the devices ourselves, we outsource this to a 3PL. We are registered with USFDA as an Initial Importer/Distributor. My company is interested in acquiring MDSAP and 13485 certification as one of our suppliers, the legal manufacturer of a device, is not licensed in Canada (and does not have MDSAP). My understanding is if the legal manufacturer is not licensed in Canada, we cannot sell the device in Canada. My question is, if we, the importer/distributor of the device, were to obtain MDSAP and 13485 certification, are we able to apply for a Medical Device License and sell the device in Canada ourselves? Your feedback is appreciated!