Health Canada Clarifies Performance Targets, Reports Decline in MDL Submissions

Health Canada’s intake of Medical Device License (MDL) applications has shown a slow but steady decrease in the regulator’s number of license approvals from 2011 to mid-2016.

Health Canada Medical Device License MDL review performance 2016According to the latest annual performance report published by the regulator, the numbers of MDL submissions for Class II, III and IV devices have generally declined since 2011; there were reduced numbers of submissions across all three classes for Health Canada’s 2015/2016 year over the prior year, as well as a general trend showing less submissions per year over the past five years:

Year

Class II

Class III

Class IV

2011/12

4961

2101

720

2012/13

4674

1807

633

2013/14

4459

1902

753

2014/15

4270

1791

586

2015/16

3894

1650

569

                                           Sources: Emergo, Health Canada

Impact of labeling requirements

Health Canada also recently published a quarterly performance report covering January to March 2016 that clarified the regulator’s performance targets for MDL reviews at 15 days for Class II license applications, 60 days for Class III applications and 75 days for Class IV applications once submission requirements are satisfied.

“One year prior, in July 2015, Health Canada published an update to the Canadian Medical Devices Regulations (CMDR) whereby applications for Class II devices would require inclusion of labeling,” explains Daryl Wisdahl, Managing Director of Emergo’s Canadian office. “Previously, manufacturers would just sign an attestation that their labeling was in compliance with Sections 21 to 23 of the CMDR.”

Before the new labeling requirements were introduced, Wisdahl notes that a review of Health Canada data showed that about 11% of Class II MDL submissions took longer than the regulator’s 15-day performance target. But in the fourth quarter of Health Canada’s 2015/2016 fiscal year, more than 40% of Class II submissions exceeded that 15-day target.

“While Emergo has always included labeling with Class II submissions prepared for our clients, we have noticed that Health Canada has dramatically increased their oversight of device labeling,” Wisdahl says. “This has indeed led to more questions from Health Canada with respect to the content of device labels, slowing the review process.”

To learn more about Canada’s MDL approval process, download our whitepaper or view our video overview of Health Canada registration. 

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