Market Access-

Canada

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To gain access to the Canadian market you will likely need a license as issued by Health Canada. Dependent on the class of your device and route to market you will either require a Medical Device Establishment License (MDEL) or a Medical Device License (MDL).
In addition to this license you will require proof you have an ISO 13485 certified quality management system under the Medical Device Single Audit Program (MDSAP) which fulfils the criteria as specified by the Canadian Medical Device Regulation (CMDR). 

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