The deadline for the Medical Device Active License (MDAL) renewal in Canada is approaching.

In compliance with clause 43(1) of the Canadian MDR SOR 98/282, in fact, by November 1st of each year the manufacturers of licenced Medical Devices or their respective Canadian Regulatory Correspondent, if different, must inform Health Canada about the correctness of the data previously communicated regarding the manufacturer and the device otherwise provide evidence of any changes.

At the same time, the manufacturer must also communicate to Health Canada the quantity of devices sold during the period, the basis upon which the tax to be paid for the maintenance of the licences is calculated.

Contravening this obligation could result in the cancellation of licences and the consequent sale interruption of the devices on the Canadian market.


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