Based on the “Fees in Respect of Drugs and Medical Devices Order”, Health Canada published the updated fees for Medical Devices applicable as from 1st April 2022.
What are the updated fees for Medical Devices?
As you can see in the chart below, Medical Device License application fees, expressed in Canadian dollars, have increased compared to 2021:
|Category||Fees as from 1st April 2021||Fees as from 1st April 2022|
|Applications for Class II licence||$ 478||$ 522|
|Applications for Class II licence amendment||$ 272||$ 282|
|Applications for Class III licence||$ 8.895||$ 10.679|
|Applications for Class III licence amendment – changes in manufacturing||$ 2.375||$ 3.070|
|Applications for Class III licence amendment – significant changes not related to manufacturing||$ 7.543||$ 8.780|
|Applications for Class IV licence||$ 24.699||$ 25.955|
|Applications for Class IV licence amendment – changes in manufacturing||$ 2.375||$ 3.070|
|Applications for Class IV licence amendment – significant changes not related to manufacturing||$ 9.964||$ 12.128|
|Applications for Class II, III or Class IV licence or licence amendment – private label medical device||$ 147||$ 152|
Compared to 2021, there has also been an increase in the fee for the examination of an application Medical Device Establishment Licence that as from 1st April 2022 is equal to $ 4.737.
The annual fee for the right to sell a licensed Class II, III or IV medical device increased as well. As from 1st April 2022 it will be $ 394, while last year it was $ 381.
Would you like to have further information about Medical Devices Regulation in Canada?
Thema’s experts are available for a consultation to provide you with useful information on the Canadian regulatory scenario, they can support you during the registration process to market your devices in Canada in full compliance with the regulations.
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