With limited exceptions, you must have an MDL or an MDEL to import or sell Class II medical devices. Health Canada maintains a searchable MDL database and MDEL database .
Additional guidance regarding MDL and MDEL licensing requirements is available on Health Canada’s website, here and here.
Medical devices must be labelled in French and English with all information required by applicable Canadian law, including but not limited to:
Additional guidance on medical device labelling is available on Health Canada’s website, including here.
Medical devices may not be illegally marketed. Examples of illegal marketing include:
More information here: