During the COVID-19 pandemic, Health Canada rapidly adjusted its regulatory procedures to ensure the timely availability of essential medical devices such as face masks, gloves, and testing kits. To address the surge in demand, the standard policy required applicants to pay a fee to Health Canada for reviewing their license applications. However, between April 2020 and December 2021, Health Canada altered its process and conducted reviews before issuing invoices or collecting payments. The intention was to expedite the provision of critical medical devices.

This adjustment to procedure led to several applications being processed and approved prior to fee collection. A significant number of licences were subsequently cancelled by Health Canada before February 2022. Despite these cancellations, the fees for the services performed remained outstanding. To address this financial discrepancy, Health Canada has implemented the Medical Device Establishment Licence Fees Remission Order (Expedited Examination of Applications During the COVID-19 Pandemic).

Health Canada is responsible for the regulation of medical devices and pharmaceuticals in Canada and typically charges a fee for the review of licence applications. During the pandemic, to facilitate the swift approval of vital medical devices, Health Canada modified the timing of fee collection. The usual procedure, which involves invoicing and collecting fees before the review process, was temporarily suspended.

Between April 2020 and December 2021, Health Canada reviewed a total of 6,950 medical device establishment licence applications. Out of these, 2,439 licences were cancelled before February 2022. Despite these cancellations, the fees for the review services still remained due. The discrepancy arose because the services were rendered prior to the collection of fees, leading to an outstanding debt.

The Remission Order provides for the cancellation of fees associated with applications reviewed during this specified period, provided the licence was cancelled prior to February 2022. The Remission Order aims to forgive the fees and aims to alleviate the financial impact on affected businesses.

The Remission Order is anticipated to relieve the industry of approximately $10.2 million in fees that were accrued during the period when applications were reviewed before payment was received. The total cost to the government for implementing this remission, including administrative expenses, is estimated to be $10.3 million.

The Remission Order will automatically remit fees for all qualifying applications. Health Canada plans to finalize this process by spring 2023, including any necessary refunds. Affected applicants will be contacted directly if additional information is required.

Canada (SOR/2023-36), March 15, 2023