Medical Device Licence Fee Remission

Summary#

The Medical Device Establishment Licence Fees Remission Order (Expedited Examination of Applications During the COVID-19 Pandemic) lets Health Canada waive certain licence fees that became a debt during the pandemic. It refunds or cancels fees for specific establishment‑licence applications that were examined without payment between April 1, 2020 and December 31, 2021, and then cancelled before February 1, 2022.

What it does#

• Remits the fee (and any interest) charged under the Fees in Respect of Drugs and Medical Devices Order for:
  • applications for a new establishment licence (under the Medical Devices Regulations) and
  • applications for the annual review of an establishment licence.
• Applies only when:
  • the application was examined by Health Canada between April 1, 2020 and December 31, 2021;
  • the examination happened before the applicant had paid the fee; and
  • the licence was issued or reviewed but then cancelled on or before February 1, 2022.
• Covers cases whether or not an invoice was ever issued. It also reimburses applicants who already paid.
• The order took effect on the day it was registered (February 28, 2023).
• Estimated financial effects:
  • 6,950 applications were processed in that period.
  • 2,439 licences (about 35%) were later cancelled.
  • Of those cancelled, 580 had paid fees, 244 had unpaid fees, and 1,615 were never issued an invoice.
  • Total fees to be remitted are about $10.2 million, plus an estimated $100,000 to process the remissions, for a total government cost of about $10.3 million.

Who's affected#

• People and businesses that apply for or hold a medical device establishment licence — typically manufacturers, importers and sellers of medical devices in Canada.
• Specifically, applicants whose licence applications were:
  • submitted and examined between April 1, 2020 and December 31, 2021,
  • examined before fee payment, and
  • cancelled before February 1, 2022.
• Applicants who already paid will get reimbursed.
• About 35% to 45% of licence holders are estimated to be small businesses, so many small firms may benefit.

Why it matters#

• It fixes an unintended outcome from Health Canada’s pandemic response. During COVID‑19, applications were sometimes examined before payment to speed access to supplies. That created debts to the Crown when licences were later cancelled.
• The order clears that debt for affected applicants and refunds those who paid. That reduces financial surprise and burden for businesses, including many small firms.
• It has a one‑time cost to the government (about $10.3 million) but removes administrative and fairness issues tied to the temporary pandemic practice.
• Health Canada now examines applications only after invoicing and payment (as of end of December 2021), so the problem is limited to the pandemic period described above.