Early in August of each year, Health Canada sends each manufacturer who is marketing licensed Class II, III or IV medical devices in Canada an annual licence renewal package to help the manufacturer fulfil their regulatory obligation. The annual renewal of active medical device licenses is due by November 1st each year. If you need assistance with the annual renewal of your medical device, please contact us today!
Failure to renew active medical device licenses and comply with section 43 of the Medical Device Regulations may result in the cancellation of the existing licence(s). The invoicing process, occurring in December of each calendar year, will bill only valid renewed medical device licences.
Medical device licences that are not renewed have either been discontinued by the manufacturer or have been cancelled by the Medical Devices Directorate for failure to renew by the November 1 deadline.
If a medical device licence has been cancelled, the product is no longer permitted to be offered for sale in Canada. In order to bring the medical device back into compliance, the manufacturer must submit a new medical device licence application to the Medical Devices Directorate, as well as pay all applicable fees.
Manufacturers wishing to renew must wait for their invoice from Health Canada, which will be sent in December, before submitting their payment. Instructions on the payment of fees are further outlined in the document available on the official website of Health Canada (Call 1800-396-5144 for details). All payments must be in Canadian funds. Cheques must be made payable to the “Receiver General for Canada”.