Ontario Regulation 438/07

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

10 Responses to Ontario Regulation 438/07

  1. You state that 438/07 applies only to medical devices, but I find nothing to that effect in any of ESA’s statements, nor does the word “medical” appear in the statute. From all that I can see, this applies to ANY electrical product being sold in Ontario.

  2. Tom Fortin says:

    Ontario Regulation 438/07 DOES NOT mandate any registration reguirements by either medical or electrical equipment manufacturers. The ESA has yet to have the regulation ammended. We are fighting the mandatory registartion requirements.
    Please see http://www.ontrak.net/esafe.htm for details.

  3. Paul O'Shaughnessy says:

    Quite right. I received that idiotic letter from the ESA. Even their letter calls the registration and fee structure “in addition” to 438/07 – it has no basis in law. Additionally, it flies in the face of decades of harmonization and is simply an excuse for them to fund another bureaucracy. They are saying that even if a product is certified to CSA standards, it is inappropriate for sale in Ontario unless we register and pay them. I call it extortion. Imagine the damage should other provinces and states decide to impose their own little registration fees. I cannot believe there is not a greater outcry against this nonsense.

  4. Thanks for the additional information. My doubts are gone – ESA considers this a done deal. The ESA doesn’t answer any questions – they simply state that 438/07 authorizes them to establish these fees and sanction any manufacturer who does not comply. The fact that 438/07 mentions none of this deters them not at bit.

    Follow the money. They are not going to back away from this potential revenue stream and will simply repeat their boilerplate answer over and over, justifying it because they say it is so. Black is white, up is down, because they say so. This is NOT about product safety. It is about making lists, checking them twice, finding out who is naughty or nice, and by the way cranking $350 out of EVERY electronics manufacturer on the planet who happens to sell something in Ontario.

    Nice work if you can get it. I’ll get off my soapbox now.

  5. More money says:

    Just think: 50 states x 350.00 each = 15K per year. Hope Ontario realizes this kind of extortion goes both ways. Do they have anyone making electrical items in their apparently underfunded province?

  6. Ryan Jayasinghe says:

    And if you build to order as we do, you may not have a sale into Ontario but yet have to ‘register’ in the event there maybe a sale later!
    And what if you only sell one a year-there goes your profit-you are not going to tack on the fee to your only sale.

  7. Richard S. says:

    The original registration deadline (August 30, 2009) has been postponed indefinitely. (Thanks, Tom.)


    The government and ESA have heard from industry about concerns with the proposed manufacturer registration system. The Electrical Safety Authority wishes to advise electrical product manufacturers and other industry stakeholders of the decision to postpone the August 30, 2009 deadline for the registration program.

    We want to thank those who have already registered, and assure them that ESA will extend the duration of their registration as appropriate.

  8. This is good news, but note that ESA is speaking of “postponement” of the deadline and assuring that registratons will be “extended”, rather than a cancelation of the program. I am guessing that some people at ESA think this might still be made to work and are hedging their language. Remain vigilant!

  9. I saw that Stakeholders are invited to take part in the guideline development process.

    You can contact Maria Iafano, Regulatory Affairs Analyst at 905-712-5379 with questions regarding the guideline development process.

    Check out
    Stakeholder Consultation Invitation-

    Click to access Stakeholder_Consultation_Invitation.pdf

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