By Stewart Eisenhart, Emergo Group
The number of Medical Device License (MDL) and amendment applications to Health Canada’s Medical Devices Bureau (MDB) has declined over the first quarter of 2012, according to Canadian medical technology industry trade group MEDEC (registration required).
Health Canada received 1180 applications during Q1 of 2012, which is 12% lower than the average volume of applications received in Q4 of 2011 and 15% lower than the average volume of applications received over the last four quarters, MEDEC claims.
Volume versus Performance
MEDEC examined application volumes according to device class, as well: Class II applications decreased one percent from Q4 2011 to Q1 2012; Class III application volumes fell by 16%; Class IV applications decreased by five percent; and amendment applications fell by 19%.
But market authorization timeframes have also increased on the MDB’s side, according to MEDEC’s findings. Although application review target times for Class II devices is 15 days, actual review times averaged 24 days for new applications and 37 days for amendments for Q1 2012.
Target timeframes for Class III device application reviews by the MDB are 75 days, but actual times averaged 160 days for new applications and 111 days for amended applications over the first three months of 2012.
Market authorization times for Class IV devices, however, improved between Q4 2011 and Q1 2012. Although still behind target review timeframes of 90 days, new application reviews for the first quarter of 2012 fell to 163 days from 230 in Q4 2011. Amended applications for Class IV devices, however, saw increased review times—from 99 days in Q4 2011 to 123 days in Q1 2012.
While it appears that Health Canada has made some headway in terms of reviewing high-risk device applications, manufacturers of Class II and III devices still face considerable market authorization delays when it comes to medical device registration in Canada.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
