The Department of Health, Health Canada published the Fees in Respect of Drugs and Medical Devices Order, the annual adjustment of the new fees for Medical Devices for the fiscal year 2023-2024, which came into effect on 1 April 2020 and subsequently revised in March 2021 during the pandemic.

The new fees will be applicable as of 1 April 2023.

As stipulated in Section 4.1 of the Fees in Respect of Drugs and Medical Devices Order, each fee under the Order has to be increased annually according to the Consumer Price Index (CPI). The fees for the fiscal year 2023-2024 are subject to a CPI of 6.8%, which has resulted in an increase in the fees for establishment and medical device licence applications.

Product licence fees for Medical Devices are only applicable to applications for Class II, III and IV Medical Devices, according to Canadian regulations.

All devices in these classes must obtain a product licence (MDL or MDAL) in order to be marketed in Canada.

Fees for the Medical Device Establishment Licence (MDEL) are issued for activities involving the importation or distribution (sale) of Medical Devices for Human Use in Canada and are also required for Class I Medical Device Manufacturers who do not sell exclusively through an Authorised Canadian Importer or Distributor. Fees are charged for the initial MDEL, for subsequent annual licences and for reinstatement of an MDEL. Fees are applied equally to foreign and domestic establishments, with the exception of certain exemptions.

Below is a summary and comparison table between the 2022 fees and the new fees for Medical Devices that will come into force on 1 April 2023:

Table 7: Fees for examination of an application for a medical device licence (Schedule 8)
Section in the Fees in Respect of Drugs and Medical Devices Order	Category	Fee as of April 1, 2022	Fee as of April 1, 2023
Section 60	Applications for Class II licence	$522	$589
	Applications for Class II licence amendment	$282	$302
	Applications for Class III licence	$10,679	$12,987
	Applications for Class III licence (near patient)	$20,723	$27,666
	Applications for Class III licence amendment — changes in manufacturing	$3,070	$4,098
	Applications for Class III licence amendment — significant changes not related to manufacturing	$8,780	$10,425
	Applications for Class IV licence	$25,955	$28,165
	Applications for Class IV licence amendment — changes in manufacturing	$3,070	$4,098
	Applications for Class IV licence amendment — significant changes not related to manufacturing	$12,128	$14,902
	Applications for Class II, III or IV licence or licence amendment — private label medical device	$152	$163

Table 8: Fees for examination of an application for an establishment licence — Medical Devices
Section in the Fees in Respect of Drugs and Medical Devices Order	Fee category	Fee as of April 1, 2022	Fee as of April 1, 2023
Section 71	Medical Device	$4,737	$5,060

Table 9: Fees for right to sell licensed Class II, III or IV Medical Devices
Section in the Fees in Respect of Drugs and Medical Devices Order	Fee category	Fee as of April 1, 2022	Fee as of April 1, 2023
Section 77	Medical Device	$394	$421