Advancing Healthcare Through Innovative Technologies and Devices
Medical Devices Bureau (MDB) Performance
Based on current performance reports available from Health Canada there is some backlog build-up in applications at the MDB. The average Time to 1st Decision appears not affected. However, the current ‘Time to Market Authorization’ 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 only 30% of applications complete review without screening deficiencies and additional information requests. While these applications are completed within the performance targets, the remaining 70% take on average 2-3 times the target timelines due to time needed to obtain and review the deficient information.
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 Q4 2015/16 Performance Report can be found here (English) and here (French).
Health Canada's Medical Device Bureau 2015/16 Annual Report can be found here (English) and here (French).
MEDEC is the national association created by and for the Canadian medical technology industry. MEDEC is the primary source for advocacy, information and education on the medical technology industry for members, the greater healthcare community, industry partners and the general public.
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