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:

  1. Quantitative risk-based approach: HC would use a series of risk factors—compliance history, mandatory problem reports and recalls, for example—to classify and score an MDEL holder. Higher risk scores would result in more frequent inspection cycles.
  2. Frequency determined by activities conducted and prior inspection records: A license holder’s activities being conducted—manufacturing, importing or distributing—as well as the firm’s previous inspection results determine inspection cycle frequency.
  3. Facility and device class: HC would employ a matrix to cross-examine a license holder’s type of facility and device class, and then determine how often that firm should be inspected.
  4. Intrinsic and compliance risk: Combining aspects of the first three approaches, this three-step option would first determine levels of risk intrinsic to a license holder’s activities (highest risk is assigned to manufacturers versus importers or distributors). Then, HC would consider the firm’s compliance risk based on its prior inspection record. Third, intrinsic and compliance risks would be adjusted based on other risk factors and inspection cycles would be determined accordingly.

Comments are due by November 16, 2011.


  • Stewart Eisenhart