Join   |   Contact Us   |   Print Page   |   Sign In
Medical Devices Bureau Performance Report
Share |
Advancing Healthcare Through Innovative Medical Technologies


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). 



Member Login



Medtech Canada is the national association representing the medical technology industry in Canada. Our association advocates for achieving patient access to leading edge, innovative technology solutions that provide valuable outcomes. Our members are committed to providing safe and innovative medical technologies that enhance the quality of patient care, improve patient access to health care, and help enable the sustainability of our health care system. The medical technology industry in Canada employs over 35,000 Canadians in approximately 1,500 facilities across the country.

Toronto Office

900-405 The West Mall
Toronto, ON M9C 5J1

Quebec Office

204, Notre-Dame O.   Bureau 402
Montréal, Québec H2Y 1T3

(514) 217-1167