Canada’s MDB Struggled to Meet Market Authorization Timelines in 2010

According to MEDEC, the Canadian medical device industry trade association, Health Canada’s Medical Devices Bureau (MDB) faced a persistent backlog last year when it came to processing market authorization applications in a timely manner.

MEDEC characterizes the backlog as primarily an effect of increasing application volumes: For the whole of 2010, the MDB saw a 10% increase in application volumes, with new versus amendment applications making up about 60% of that increase.

Class II applications represent three-fourths of MDB’s new application volumes, and increased nine percent from 2009. Class III new applications actually decreased by one percent, while Class IV new applications increased by 18%.

MDB’s performance in terms of meeting approval timelines was a mixed bag in 2010, according to research published by MEDEC in its Pulse newsletter. For Class II devices, the regulator improved its processing times for new applications compared to 2009, and was able to approve amendment applications within target times.

Class III and Class IV market authorizations, however, typically took twice the MDB’s target time (160 days instead of 80 for Class III applications, and 180 days instead of 90 for Class IV applications).

Although MEDEC does not directly suggest any solutions to the backlog in its newsletter, there are two obvious approaches to take in order to speed up MDB’s application processing: Either advocate more resources to Health Canada in order to handle growing volumes, or amend the Canadian regulator’s methods for processing market authorization applications. Throwing money at this particular problem may prove easier than trying to amend regulatory policy.

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