DRW Monthly
June 2009
Issue No. 31

Health Canada Proposes Reforms to its Investigational Device Testing Regulatory Framework

Over the past few years, Health Canada has been engaged in a reform initiative to strengthen its risk management approach to device investigational testing (IT). The initiative, outlined in the agency's Medical Device Program (MDP) report, Building for the Future, is part of a broader five-year strategic plan, from 2007 to the end of 2012, to become more proactive in updating the overall device regulatory process. Health Canada commenced this particular undertaking in response to a report issued by the Auditor General of Canada in March 2004. In summary, the Auditor's report determined that Health Canada's approach to managing risks associated with medical device IT was inconsistent with its clinical trial activities for other therapeutic products and recommended that the agency take appropriate action to improve this program.(1)

The first step taken by Health Canada to address the Auditor General's evaluation was to launch a public online consultation with medical technology industry stakeholders. The consultation was held from July 25th to October 25th, 2007. Areas of review included good clinical practice (GCP) requirements, trial site inspections and interim/final reporting of significant risk IT to Health Canada. Participants were asked to complete the online survey contained in an electronic document entitled, Discussion Paper for Consultation: Proposed Changes to the Regulatory Framework for Investigational Testing of Medical Devices.

Health Canada recently released the conclusions compiled from this online stakeholder consultation in its Posting of Stakeholder Input: Proposed Changes to the Regulatory Framework for Investigational Devices (May 2009). The majority of respondents agreed that a consistent approach for managing risk in trials across the spectrum of therapeutic products would ensure that 'best practices' are improved. In addition, the survey received widespread support on the issue of aligning the device IT framework with other international regulatory authorities using established international standards. The consensus was that increased international harmonization and collaboration would encourage research in Canada, ensure that Health Canada remains internationally credible and increase international cooperation. Finally, respondents strongly advocated an amended regulatory framework that would require Health Canada to conform with GCPs in accordance with the ISO 14155 standard; establish an inspection program for device IT sites; call for interim/final reporting of significant risk IT to the agency for review/monitoring; ensure harmonization with other international counterparts, including implementing the term "clinical investigation"; and develop further guidance documents relating to device IT.(2) Health Canada is currently using this feedback in conjunction with additional contributions from Canada's national industry association, Medical Device Technology Companies (MEDEC), to advance its goal of strengthening the IT device regulatory framework.

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