Fees Apply to COVID-19 Medical Devices

Summary#

The Order Amending the Fees in Respect of Drugs and Medical Devices Order (COVID-19 Medical Devices) updates fee rules so that some COVID‑19 medical devices will start facing the same fees as other medical devices once they are no longer treated as an “urgent public health need.” It was registered February 6, 2023 and published in the Canada Gazette on February 15, 2023.

What it does#

• Changes the Fees in Respect of Drugs and Medical Devices Order so fees apply to certain COVID‑19 medical devices once they are removed from the List of Medical Devices for an Urgent Public Health Need (the UPHN list).
• Adds examination-fee categories for applications to amend authorizations for Class II, III and IV COVID‑19 medical devices that are not on the UPHN list.
• Sets the annual “right to sell” fee for a licensed or authorized Class II, III or IV COVID‑19 medical device (not on the UPHN list) at $381. The fee is payable by the licence holder or the authorization holder.
• Keeps the existing small business reductions: 25% off the annual right-to-sell fee and 50% off certain examination fees for qualifying small businesses.
• Updates the performance standard reference to the document dated November 1, 2022.
• Explains timing for annual renewals and billing: annual renewal information is due November 1 and invoices are issued by December 20 (as described in the order).
• The amendments come into force when the related amendments to the Medical Devices Regulations (the permanent COVID‑19 pathway, Part 1.1) come into force — effectively when the temporary interim order framework ends.

Who's affected#

• Manufacturers, importers and distributors of Class II, III and IV COVID‑19 medical devices that were authorized during the pandemic — especially those whose devices leave the UPHN list.
• Holders of authorizations issued under the COVID‑19 interim orders who want to keep selling their devices after the urgent‑need designation ends.
• Small businesses that may qualify for the reduced fee rates.
• Class I device manufacturers are largely unaffected by these specific fee changes while their devices remain on the UPHN list; different licence rules apply once their devices are removed from that list.

Why it matters#

• If a COVID‑19 device is no longer seen as urgently needed, its maker will begin to pay fees (application amendment review fees and an annual right‑to‑sell fee). That can raise costs for companies that choose to keep selling those products in Canada.
• The change aligns COVID‑19 device fees with the normal medical-device system. It helps Health Canada recover review and oversight costs once emergency conditions end.
• Some manufacturers might stop selling certain devices in Canada because of the new cost or regulatory requirements, which could affect availability of specific tests or equipment — although the rule keeps fee relief for qualifying small businesses.