This update is intended for medical device manufacturers and those interested in the regulation of medical devices.

Health Canada recently released two significant forward-looking documents on the regulation of medical devices:

  • Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality (Action Plan); and
  • Draft Guidance Document: Pre-market Requirements for Medical Device Cybersecurity (Cybersecurity Guidance)

These publications are expected to inform changes to Canada's medical device regulatory regime to expand Health Canada's device licensing and monitoring oversight activities as well as to encourage manufacturers to address emerging security vulnerabilities in networked devices.

Action Plan

The Action Plan provides a three-part strategy to address perceived gaps in Health Canada's oversight of medical devices, with particular emphasis on (A.) investigational testing prior to device licensing and expanding scientific expertise, (B.) monitoring of licensed devices through increased reporting of device incidents, and (C.) providing more clinical and device incident data to the public. Each part of the strategy is summarized below:

A. Investigational Testing and Scientific Expertise: Currently, only device manufacturers are permitted to apply for an investigational testing authorization involving unlicensed devices. The proposed changes will allow independent researchers and health care professionals to file an application for investigational testing, with the aim of expanding the scope of Canadian research and generating more safety testing data. In this regard, Health Canada has indicated that it will be publishing a Notice of Intent (presumably to amend the Medical Devices Regulations) in June 2019 and a subsequent report of its consultation findings in September 2019.

Continue reading to learn more about upcoming changes to Canada's medical device regulatory regime and new compliance obligations for device manufacturers and other health care industry stakeholders.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.