It’s going to get much more expensive to market medical devices in Canada.
Health Canada recently said that makers of Class II, III and IV devices will have to pay 75% of its costs for pre-market evaluations, 67% of right-to-sell application costs and 100% for establishment licenses. That’s up from the 43% regulatory costs the agency has been collecting from the industry.
The new fees, set to go into effect beginning on April 1, 2020, will be set at 50% to 100% of costs, with most will be phased in over four to seven years.
Here’s a sampling of the increased fees, in Canadian dollars:
- A Class II license application will cost $450 in fiscal year 2020-21 and $533 in FY 2023-24.
- A Class III license application will cost $7,477 in FY 2020-21 and $11,783 in FY 2023-24.
- A Class III license application for a near-patient in vitro diagnostic device will cost $12,851 in FY 2020-21 and $25,102 in FY 2023-24.
- A Class IV license application will cost $24,345 in FY 2020-21 and $25,554 in FY 2023-24.
Fees for amending device applications, opening a medical device business and for the right to sell Class II, III and IV devices will also rise. The Canadian government began charging fees for medical device regulatory services in the mid-1990s and last updated them in 2011.
“Currently, Health Canada fees are not reflective of the costs to deliver its regulatory programs,” the agency said in its final rule, published in the Canada Gazette last week. “New regulatory challenges stemming from increasingly complex submissions; greater risks from counterfeit or contaminated products; and increased volume of products imported into Canada means Health Canada must adapt in order to continue maintaining the effective and efficient delivery of its regulatory activities.”
Fees will be adjusted annually based on the Consumer Price Index, rather than the current 2% annual adjustment.
It could have been worse. Health Canada had initially proposed raising its medical device application fees to 90% of costs, but lowered them to 75% of costs following industry objections.
