By Stewart Eisenhart, Emergo Group
Canadian medical technology industry trade group MEDEC has found both decreasing volumes of applications sent to Health Canada’s Medical Devices Bureau (MDB) in the second quarter of 2011 as well as delayed market authorizations for the bulk of submitted applications due to recent regulatory changes.
Following Health Canada’s implementation of the Cost Recovery Act that raised user fees beginning last April, the number of Class II applications to the MDB decreased by 17% compared to the first quarter of 2011; Class III applications decreased by 33% and Class IV applications fell by 45% over the same period. Overall, applications to the MDB decreased 17% from Q1 2011 volumes.
More than 70% of Class II applications were deemed to have screening deficiencies by the MDB, attributed to fee and application form changes. Class III applicants saw even bigger delays: 95% of these applications had screening deficiencies, while more than half generated requests for more information from the MDB.
More than 95% of Class IV applications had screening deficiencies, and 55% of applications prompted additional information requests.
MEDEC acknowledges that drawing any conclusions regarding systemic market authorization delays at the MDB would be premature given how recently Health Canada’s revised fee structures went into effect. In the short term, however, applicants unaccustomed to the Canadian market’s new fee requirements should not be surprised by longer-than-expected review times.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.