HEalth canada Medical Devices Bureau (MDB) Performance
Based on current performance reports available from Health Canada there has been some significant backlog build-up in applications at the Medical Devices Bureau (MDB) in Q1 and Q2, FY 2016/17 due to substantial capacity shortage. Efforts were made by MDB to combat this trend, which led to noticeable improvements in Q3. The average Time to 1st Decision for a number of review lines was affected.
The current ‘Time to Market Authorization’ (time from application submission to licence issued including stop times for responding to Screening Deficiency Letters and/or Additional Information Requests by the applicants) for all classes of medical devices is on average between 2-3 times the published target timelines (= ‘Time to 1st Decision’).
Health Canada notes that currently 50% of applications arrive at MDB with screening deficiencies and 40 – 60% of applications complete review with additional information requests. While flawless applications are completed within the performance targets, the deficient applications take on average 2-3 times the target timelines.
MEDEC is working with Health Canada to find solutions to the issues related to application quality and performance that delay market access.
Health Canada's Medical Devices Program Q1 2016/17 Performance Report - English and French.
Health Canada's Medical Devices Program Q2 2016/17 Performance Report - English and French.
Health Canada's Medical Devices Program Q3 2016/17 Performance Report - English and French.
Health Canada's Medical Device Bureau 2015/16 Annual Report can be found here (English) and here (French).