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- Draft Guidance Document: Pre-market Requirements for Medical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.
