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Regulation of Medical Devices and Problem Reporting in Canada

presented by James Barr, Medical Devices Specialist, Health Canada

Webinar sponsored by Health Canada & ACCES


Date & Time: February 17, 2010 at 2 p.m. (Atlantic Time)


This webinar will outline how medical devices are regulated in Canada under the Medical Devices Regulations.  Special emphasis will be placed on problem reporting and in particular, the role of hospitals and biomedical engineering staff.  Topics will include:

  • Overview of the Medical Devices Regulations
  • classification of medical devices
  • device licensing
  • Establishment licensing & required procedures (Complaint handling, Recalls etc.)
  • regulation of imported versus domestic devices
  • mandatory and voluntary problem reporting (how the process works)
  • the key role of hospitals, device users and the biomedical engineering staff
  • the Canadian Medical Devices Sentinel Network Pilot
  • counterfeit health emerging risk