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Electro Medical Safety Devices

Electro Medical Safety Devices

Update on Incident Reporting for Electro-Medical Devices

If you are a manufacturer, importer, distributor, retailer, seller or advertiser of electro-medical devices in Ontario, please note the following important change:

Effective July 1, 2011, electro-medical device businesses are exempt from the electrical product incident reporting requirements under the Ontario Product Safety regulation (O.Reg. 438/07), which required reporting to the Electrical Safety Authority.  You will continue to be required to submit incident reportsinvolving electro medical devices to Health Canada.  Health Canada is the regulator of all aspects of medical device safety, including electro-medical devices.

Please note that the Electrical Safety Authority (ESA) continues to be responsible for the oversight of the approval (certification or field evaluation) requirements for electro-medical devices as set out under the Ontario Electrical Safety Code and the Product Safety regulation.  This approach is consistent with that of other provinces and territories in Canada.

This change has been made to eliminate duplicate incident reporting requirements while maintaining public safety.