Ontario Regulation 438/07

March 18, 2009

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 Cost and Where to register

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.

You should update your ISO 13485:2003 quality system procedure for incident reporting as needed.

Only applies to

Just to reiterate, this regulation only applies to medical devices with an electrical component being sold in Ontario.

Source:ESA website