Medical Device Licence Renewal Deadline 1 November: How to Avoid Cancellation

Every year, hundreds of Canadian medical device companies risk losing the legal right to sell their products for one avoidable reason: they do not complete the annual medical device licence review before 1 November. The renewal is short, the fee is modest, and the process is predictable. The consequence of missing it is not. A cancelled medical device licence cannot simply be reactivated. The device comes off the market, and the manufacturer has to file a brand new licence application to sell it again.

If you hold a Health Canada medical device licence for a Class II, III or IV device, the renewal package has already gone out and the clock is running. This guide explains exactly what the annual licence review requires under section 43 of the Medical Devices Regulations, what the fee for the right to sell is in 2026, what happens if you miss the deadline, and how to protect your market access with a few simple controls.

Executive summary

Under section 43 of the Medical Devices Regulations (SOR/98-282), every manufacturer of a licensed Class II, III or IV medical device must send Health Canada an annual statement, before 1 November each year, confirming that the licence information is still accurate or describing the changes made. If the statement is not filed, Health Canada may cancel the licence. A cancelled licence cannot be renewed. The device must then come off the Canadian market until a new medical device licence application is approved. A separate annual fee, set at $460 per device licence as of 1 April 2026, gives the holder the right to continue selling the device.

What the 1 November medical device licence renewal is

What it is. The annual licence review, sometimes called the medical device licence renewal, is a yearly confirmation that the information on your medical device licence is still correct. Health Canada issues a renewal package, usually in late summer, and the manufacturer or its regulatory correspondent must respond before 1 November. Why it matters. A medical device licence is what makes it legal to sell a Class II, III or IV device in Canada. The annual review keeps that licence active. What to do. Review every licence you hold, confirm the details, file the statement before the deadline, and pay the fee when invoiced. How it affects compliance. Missing the review is one of the few errors that ends your right to sell automatically, without an inspection or a warning letter.

The renewal is a recertification, not a re-review of your device. Health Canada does not re-evaluate safety and effectiveness each year. It asks you to attest that nothing on the licence has changed in a way that would require different information. If something significant has changed, for example the device name, the manufacturer name, or the device itself, that is handled through a licence amendment under section 34, not through the annual statement. For the detail Health Canada expects when a device first enters the market, see our guide on what Health Canada expects in a Class III or IV medical device licence application.

Who must renew, and who does not

In short: the annual licence review applies to holders of a medical device licence (MDL), which covers Class II, III and IV devices. Class I devices do not have a medical device licence, so there is nothing to renew for them. The obligation sits with the manufacturer named on the licence, even when a Canadian regulatory correspondent files on the manufacturer's behalf.

A common and costly confusion is mixing up the medical device licence (MDL) with the medical device establishment licence (MDEL). They are different licences, with different holders, different deadlines and different renewal processes. The table below sets them apart.

If your business both manufactures licensed devices and imports or distributes them, you may have to meet both deadlines in the same year. For the establishment side, and for the related changes to the import rules, see our articles on the 3-day device import notification window and Health Canada's continuously updated recognized standards list.

What the annual renewal statement must confirm

What it is. Section 43(1) requires every manufacturer of a licensed device to furnish the Minister, annually before 1 November and in a form authorized by the Minister, with a statement that either confirms the licence information is correct or describes any changes. Why it matters. A signed, accurate statement is the whole obligation. An incomplete or unsigned statement can be treated as non-compliance.

The statement must be signed by the manufacturer or by a person authorized to sign on its behalf. It confirms, for each licence, that the information Health Canada holds is still accurate, or it lists the changes that have been made. Changes that would require a licence amendment under section 34, such as a change to the device, its name, or the manufacturer's name, are not reported through the annual statement. They must be filed separately as an amendment, and they should be resolved before you certify the licence as accurate.

The practical review you should run before signing covers:

• The manufacturer name and address exactly as they appear on the licence.
• The device name, identifier and, for device families, systems and groups, the members listed.
• Whether any change has been made that needs a section 34 amendment rather than an annual statement.
• Whether any device on the licence is no longer sold in Canada and should be addressed under section 43(3).
• The contact details for the regulatory correspondent who will receive future correspondence.

The fee for the right to sell

What it is. Separate from the annual statement, Health Canada charges an annual fee for the right to continue selling each licensed Class II, III or IV device. Why it matters. The fee keeps the licence active. It is adjusted every year on 1 April under the Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124). What to do. Budget for it per licence, and pay the invoice promptly when it arrives.

The fee is payable per device licence, per year. Health Canada invoices after you file your annual statement, typically early in the new calendar year, with payment due within the period stated on the invoice. Small businesses may qualify for fee remissions under the Fees Order, so confirm your eligibility rather than assuming the standard amount. Pay close attention when you hold many licences, because the per-licence fee adds up quickly across a large portfolio.

What happens if you miss the 1 November deadline

What it is. Section 43(2) states that if the manufacturer fails to comply, the Minister may cancel the medical device licence. Why it matters. Cancellation is not a suspension you can lift by filing late. Once a licence is cancelled, it is gone. What to do. Treat 1 November as a hard stop and build reminders well ahead of it.

When a licence is cancelled, the device can no longer be sold in Canada. To put it back on the market, the manufacturer has to prepare and submit a new medical device licence application, pay the applicable review fee, and wait for Health Canada to approve it. For a Class III or IV device, that can mean months of lost sales and a full dossier rebuilt from the current requirements, not the requirements that applied when the device was first licensed.

Discontinued devices and section 43(3)

What it is. Section 43(3) requires a manufacturer that stops selling a device in Canada to tell Health Canada within 30 days, and the licence is cancelled at the time the Minister is informed. Why it matters. You should not keep paying the annual fee for a device you no longer sell, and you should not certify a licence that is no longer active.

Use the annual review as the moment to clean up your portfolio. If a device has been discontinued, notify Health Canada so the licence is cancelled and the fee stops. If you intend to bring a discontinued device back later, remember that the licence will have to be reapplied for, so plan the timing around your commercial calendar. Keeping an accurate list of which licences are active, which are being amended, and which are discontinued is the simplest way to avoid both overpaying and under-reporting.

How to complete the renewal in five steps

1. Locate the renewal package. Find the annual licence review package Health Canada sent, usually in late summer, and confirm who in your organization received it.
2. List every licence you hold. Pull your current medical device licences and check each one against Health Canada's records.
3. Reconcile changes. Identify anything that needs a section 34 amendment and file those separately, and flag any discontinued device for section 43(3).
4. File the signed statement before 1 November. Submit the annual statement in the form Health Canada authorizes, signed by an authorized person.
5. Pay the fee when invoiced. Watch for the invoice, confirm the per-licence amount, apply any small-business remission, and pay within the stated period.

Medical device licence renewal compliance checklist

• Confirmed the responsible person and backup who monitor the 1 November deadline.
• Retrieved the annual licence review package from Health Canada.
• Listed all active Class II, III and IV device licences.
• Verified manufacturer name, address and device details against the licence.
• Filed any section 34 amendments for significant changes before certifying.
• Reported any discontinued device under section 43(3).
• Submitted the signed annual statement before 1 November.
• Budgeted $460 per licence and confirmed small-business remission eligibility.
• Paid the right-to-sell invoice within the period stated.
• Kept dated records of the statement, the submission confirmation and the payment.

Common mistakes to avoid

Assuming the fee invoice is the renewal. The fee and the annual statement are two separate obligations. Paying the invoice does not file your statement, and filing your statement does not pay the fee. You must do both.

Confusing the MDL deadline with the MDEL deadline. The device licence review is due before 1 November. The establishment licence review is due before 1 April. Teams that track only one date miss the other.

Letting the renewal package sit with the wrong person. If the regulatory correspondent on file has left or changed, the package can go unanswered. Keep contact details current all year, not just at renewal.

Trying to fix a significant change through the annual statement. Changes that need a section 34 amendment cannot be slipped into the annual confirmation. File the amendment separately and in good time.

Treating a late filing as recoverable. There is no grace period that restores a cancelled licence. The only remedy is a new application, which is slower and more expensive than renewing on time.

How MFLRC can help

MFLRC supports Canadian and international device manufacturers through the full medical device licence lifecycle, not just the annual review. Our team can run a licence-status audit across your entire portfolio, confirm that each licence is accurate, file the annual statement and any required amendments, and set up a renewal calendar so no deadline is ever a surprise again.

If your business also imports or distributes, we align your MDL and MDEL obligations, support your regulatory affairs, licensing and import and export work, and keep your quality system inspection ready through audits and gap assessments. We also help device makers who are preparing new or amended applications, building ISO 13485 and MDSAP readiness, and planning cross-border market entry. Explore our full medical devices regulatory services to see how we can reduce your regulatory risk.

Renewal package arrived and the 1 November deadline is close? Contact MFLRC for a fast licence-status review and renewal support.

Frequently asked questions

When is the medical device licence renewal due in Canada?

The annual licence review for a Class II, III or IV medical device licence is due before 1 November each year, under section 43 of the Medical Devices Regulations. Health Canada usually issues the renewal package in late summer, so the window to respond is short.

What happens if I miss the Health Canada medical device licence renewal deadline?

If you do not file the annual statement, Health Canada may cancel your medical device licence under section 43(2). A cancelled licence cannot be reinstated by filing late. To sell the device again, you must submit a new medical device licence application and wait for approval.

How much is the medical device licence fee in 2026?

The fee for the right to sell a licensed Class II, III or IV medical device is $460 per device licence as of 1 April 2026, up from $452 the year before. The fee is adjusted annually on 1 April under the Fees in Respect of Drugs and Medical Devices Order, and small businesses may qualify for a remission.

Is the medical device licence (MDL) the same as the establishment licence (MDEL)?

No. The medical device licence authorizes the sale of a specific Class II, III or IV device and is renewed before 1 November. The medical device establishment licence authorizes a business to import or distribute devices, and Class I manufacturers, and it is renewed before 1 April. Many companies hold both.

Do I need to renew a licence for a device I no longer sell?

No. If you have stopped selling a device in Canada, section 43(3) requires you to tell Health Canada within 30 days, and the licence is cancelled when you do. Reporting discontinued devices stops the annual fee and keeps your portfolio accurate.

Can a regulatory consultant file the renewal for me?

Yes. A Canadian regulatory correspondent or a consultant such as MFLRC can file the annual statement on the manufacturer's behalf, manage amendments, and track the deadline. The legal responsibility still rests with the manufacturer named on the licence, so clear communication matters.

Sources and references

• Medical Devices Regulations (SOR/98-282), section 43, Justice Laws
• Health Canada, Guidance Document: Medical Device Licence Renewal and Fees for the Right to Sell Licensed Medical Devices
• Health Canada, Fees for the right to sell licensed or authorized Class II, III or IV medical devices
• Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124), Justice Laws