New regulation for medical devices with electrical components sold in Ontario, Canada

UPDATE FROM SEPTEMBER 2009: Bowing to pressure from industry, the ESA has indefinitely postponed the requirement below. More will be posted here as it becomes known.

---------

We wanted to make you aware of a new registration and reporting requirement for medical devices with an electrical component which are sold in the province of Ontario in Canada.

Ontario Regulation 438/07 was passed in August 2007 and comes into effect this year. Between April 1 and August 30, 2009, manufacturers or their Canadian representative will need to register with the Electrical Safety Authority (ESA), the administrative authority responsible for electrical safety in Canada.

Registration before August 30 is mandatory even if your device is already cleared for sale by Health Canada. Initial registration is CAN$350 per manufacturer and the yearly renewal will cost CAN$300. The online registration form will be available on the ESA website starting April 1.

In addition to registration, manufacturers will now need to notify ESA of "serious electrical incidents or accidents" which:

• Results in death or serious injury to a person
• Has the potential to cause death or a risk of serious injury to a person

If a serious incident/accident occurs involving your product in Ontario, the ESA may also require you to assist in the investigation, notify affected parties and perform corrective actions. You will still need to file a "Medical Device Problem Report Form" with Health Canada in addition to the report required by the ESA. You should update your ISO 13485:2003 quality system procedure for incident reporting as needed.

Just to reiterate, this regulation only applies to medical devices with an electrical component being sold in Ontario. You can learn more about this new requirement at the ESA website.

Best Regards,

Evangeline Loh PhD, RAC
Vice President of Regulatory Affairs
Emergo Group Inc.

P.S. We recently added medical device registration services for Mexico. There is no information available on our website yet, but if you are interested in obtaining approval for your medical devices in this market (the second largest in Latin American behind Brazil), please contact us.