Aug 15, 2011
Health Canada is seeking comment from industry on a proposed risk-based inspection model for medical device manufacturers active in the Canadian market.
The regulator has requested comment specifically on how to assess individual medical device establishments’ risk, and on appropriate inspection cycles for varying levels of risk.
HC’s current framework for inspecting firms holding Medical Device Establishment Licenses (MDEL) limits the role of risk in determining which MDEL holders are subject to inspection, focusing inspection cycles primarily on the number of MDEL holders and their activities. Under the proposed new inspection model, two license holders pursuing similar activities would have different inspection cycles based on their particular levels of risk.
HC has proposed four options for how to establish risk-based inspection cycles:
Comments are due by November 16, 2011.
An analysis Health Canada data by Canadian medical device trade association MEDEC has found increasing review times and screening deficiencies for
Health Canada is seeking comment from industry on a proposed risk-based inspection model for medi