Mar 14, 2016

The latest performance report from Canadian medical device market regulator Health Canada shows that the agency met its device licensing and registration targets for the last quarter of 2015 and early 2016.

Health Canada’s performance targets were set at 15 days for first decisions—that is, decisions whether to issue MDLs or request additional information—for Class II Medical Device License (MDL) applications, 60 days for Class III MDL applications and 75 days for Class IV MDL applications.

New MDLs mostly on target

According to the agency’s Medical Devices Bureau Performance Quarterly Report, the average number of days to first decisions for new Class II MDLs were on target at 15 between April and December 2015; for Class III devices Health Canada was slightly ahead of target at 58 days, while for Class IV devices the agency was slightly behind target at 81 days.  

These figures suggest that Health Canada’s MDL review process is able to consistently meet first-decision goals set by the regulator.

MDL amendments

Health Canada was also mostly on or near target for processing MDL amendments, according to the MDB report. Class III and IV manufacturing amendment reviews took averages of 61 and 75 days, respectively, versus targets of 60 and 75 days.

For MDL amendments with significant changes, the regulator was also mostly on target for both Class III and IV devices.

Review backlogs up slightly

Class III and IV MDL application review backlogs, which Health Canada calculates by dividing the number of applications past their first-decision target dates by the agency’s number of applications in review, remained fairly steady throughout 2015, but increased slightly to more than 16% of MDL applications in review during late 2015 and early 2016.


  • Stewart Eisenhart