Ontario Electrical Safety Authority Postpones New Registration Requirements For Electrical Medical Device Manufacturers
The Ontario Electrical Safety Authority (“ESA”) has announced that it has postponed the recent requirement that manufacturers of electrical medical devices who sell their products in Ontario register with the ESA by August 30, 2009. This requirement was originally introduced by the ESA in April 2009 in conjunction with Ontario Product Safety Regulation 438/07, which is intended to protect consumers and the public from unapproved or unsafe electrical products, promote safe market practices for the distribution of electrical products, deter non-compliance and strengthen enforcement. Pursuant to the guidelines which accompanied this registration requirement, a failure to register would have deemed all electronic medical devices made by a manufacturer as “unapproved” for sale in Ontario and subject to investigation, public notification and fines, notwithstanding any prior medical device license issued by Health Canada.
The ESA has not indicated when or if the registration requirement will be reinstated, and according to the ESA website (www.esasafe.com), the decision to postpone was made after concerns with the system were raised by industry.
Adverse Event Reporting under the Ontario Electricity Act
Although the registration requirement has been postponed, adverse event reporting under Product Safety Regulation 438/07 made under the Ontario Electricity Act is still in force. This regulation provides that manufacturers and distributors of electrical medical devices sold in Ontario have a legal duty to report any serious electrical incident or accident or a defect in the design or function of an electrical medical device to the ESA as soon as practicable after becoming aware of such incident, accident or defect. This reporting obligation is in addition to the mandatory problem reporting provisions of the Medical Device Regulations, SOR/98-282, which require manufacturers and distributors to report adverse events to Health Canada within 10 or 30 days, depending on the severity of the event.
Following the submission of an adverse event report, the ESA has the authority to commence an investigation and require the assistance of the manufacturer, wholesaler, importer, distributor or retailer of the electrical medical device in issue. The ESA also has the authority to compel any of these parties to issue a public notice relating to a risk or defect in an electrical medical device or the occurrence of an adverse event, or to order that the electrical medical device is no longer approved for sale in Ontario. Again, the investigatory and remedial powers of the ESA in relation to electrical medical devices are in addition to the investigatory and remedial powers of Health Canada under the jurisdiction of the Medical Device Regulations.
Although Health Canada is the dominant federal regulatory authority for medical devices in Canada, manufacturers and distributors who sell electrical devices in Ontario are well advised to pay close attention to the ESA and the regulations made under the Ontario Electricity Act, and to similar electricity regulations in each province in Canada in which they carry on business.