Canada’s regulatory department for medical devices has proposed sweeping changes to its application fee structure that are likely to result in higher fees for most device manufacturers.
Published in October, Health Canada’s proposed restructuring of application fees for medical devices focuses on several key areas, as follows:
- Fee setting ratios—Most major fees, including submission/application evaluation fees, establishment licensing fees and right to sell fees, would be recalibrated to cover at least 90 percent of the estimated cost born by the agency. This compares with the current Health Canada fee structure, under which individual fees can cover as little as 50 percent of that cost.
- Annual fee adjustments—Currently, increases in fees are capped at 2 percent annually. Under Health Canada’s proposal, fees would be subject to an annual adjustment tied to Canada’s Consumer Price Index from the prior year.
- Fee mitigation provisions—Under the present structure, fees are generally deferred for those applicants who have been in business for less than a year. Further, fees are remitted to an applicant when the amount of the fees exceeds a certain percentage of an applicant’s gross Canadian sales revenue. The proposed fee structure would only waive the first submission or application evaluation fee for defined “small business” entities, and only when such fees exceed $10,000. The proposal would also waive evaluation fees for products determined to meet an “urgent public health need.”
Read the complete text of Health Canada’s proposal to increase fees applicable to medical device licensing applications. Comments on the proposal can be emailed to CRI_IRC_Consultations@hc-sc.gc.ca prior to January 4, 2018.