Fees for Urgent Public Health Devices

Summary#

This makes targeted changes to the Fees in Respect of Drugs and Medical Devices Order so fee rules match a broadened emergency medical‑device framework that goes beyond COVID‑19. It lets Health Canada charge certain amendment and annual “right to sell” fees once a device is no longer on the emergency list (the UPHN list). The order was registered December 19, 2023 and published in the Canada Gazette on January 3, 2024.

What it does#

• Updates the referenced performance rules to the document Performance Standards for the Fees in Respect of Drugs and Medical Devices Order dated September 11, 2023.
• Clarifies what counts as an “authorization” under the Medical Devices Regulations so fee rules apply to devices authorized under the expanded emergency framework.
• Adds a narrow exception so that an application to amend an authorization will not attract amendment fees if the purpose is to add a medical condition that already qualified the device as a UPHN device when the amendment was submitted.
• Revises wording in the fee schedules (including items about Class II licence amendments) to reflect the expanded scope and to remove references specifically to COVID‑19; the term “COVID‑19 medical device” is replaced by “medical device” in several places.
• Keeps the rule that devices remain fee‑exempt while they are on the UPHN list, but once removed certain fees apply (see “Who’s affected”).
• Comes into force on the same day the related Regulations Amending the Medical Devices Regulations (Medical Devices for an Urgent Public Health Need) come into force, or on registration day if that is later.

Who's affected#

• Authorization holders (manufacturers/importers) of medical devices issued under the expanded Part 1.1 emergency framework and listed on the UPHN list.
• In particular:
  • Holders of Class I devices will have a transition period (the existing 120‑day transition to Part 1 of the Medical Devices Regulations remains in place).
  • Holders of Class II to IV devices will be subject to fees for amendment applications and the annual right‑to‑sell fee once their device is no longer on the UPHN list.
• Small businesses may be eligible for existing fee reductions: 25% off annual right‑to‑sell fees and 50% off examination fees for amendments (where the small‑business rules apply).
• Health Canada and the Minister of Health are the officials responsible for adding/removing conditions and devices from the UPHN list, which triggers the fee rules.

Why it matters#

• It ensures fee rules match the government’s decision to broaden the emergency device rules beyond COVID‑19. That means Health Canada can recover processing and market‑authorization costs when devices leave emergency status.
• For manufacturers, it affects when they start paying amendment and annual fees. That can affect planning and costs for bringing an emergency device into the regular market.
• For the public, the change is mostly administrative: it doesn’t change the emergency flexibilities while a device is on the UPHN list, but it affects the post‑emergency transition and how manufacturers are charged after that.