Medical Device Establishment Licence (MDEL) Annual Review 2025: What Companies Need to Know

Posted December 3, 2025

All active Medical Device Establishment Licence (MDEL) holders in Canada must complete an Annual Licence Review (ALR) to maintain their licence. This yearly renewal ensures continued compliance with Health Canada’s medical device regulations and applies even if no business changes have occurred.

It is important to note that regulatory requirements for medical device establishment licences in Canada may differ from those in other countries, and approval in other countries does not guarantee approval in Canada.

Failure to submit your ALR or pay the associated fees before April 1 each year will result in automatic licence cancellation. The MDEL process is governed under the authority of the Food and Drugs Act, which provides the legislative framework for the regulation of drugs and medical devices in Canada.

What Is the Annual Licence Review (ALR)?

The Annual Licence Review is a mandatory renewal process required by Health Canada for all active MDEL holders. A senior official with direct knowledge of the establishment’s procedures is responsible for signing attestations and ensuring compliance during the ALR process. It helps regulators confirm that your establishment continues to meet Good Manufacturing Practices (GMP) and other regulatory standards.

The ALR must identify the legal entity responsible for the establishment, and if the site is managed by a different legal entity, procedures must be in place for that entity.

Key Dates and Deadlines

To help your business stay compliant, here are the critical milestones for the MDEL Annual Licence Review process:

Mid-November: Deadline to update contact information for your MDEL registration.
- Send updates to mdel.application.leim@hc-sc.gc.ca.

December: Health Canada sends the ALR application package, which includes the ALR form, to the listed establishment contact. The ALR form is used to confirm and update contact details, mitigation status, and active medical device licences (MDLs).

Mid-January: If you have not received your ALR form or package, notify Health Canada immediately.

Before April 1: Submit your completed ALR package and ensure fees are paid.

Missing any of these deadlines may result in licence cancellation.

Submitting the ALR Package

Once received, review your Annual Licence Review package carefully.

Even if no business details have changed, the ALR must be submitted by email with confirmation of accuracy. The 120-day review period begins only once a complete application is received.

After submission:

Health Canada performs a preliminary review to ensure a complete application has been submitted. Health Canada’s performance standard for review is 120 days from receipt of a complete application.
An invoice is issued.
Fees are due upon issuance of the invoice and must be paid within 30 calendar days of the invoice date.

MDEL Fees and Small Business Fee Mitigation

Health Canada charges an annual fee for the MDEL renewal. However, small business applicants may qualify for a 25% fee reduction through the Small Business Fee Mitigation Program.

New fees and fee adjustments are periodically introduced by Health Canada, and the same fee applies regardless of when the application is received. The applicable fee is determined according to Health Canada’s regulations and is subject to annual adjustments based on the consumer price index.

Official fee changes and remission orders are published in the Canada Gazette.

Key reminders:

Apply for small business status before submitting your ALR. Small businesses must meet specific criteria to qualify for fee reductions.
Status renewal is required annually and may take up to two weeks.
Failure to maintain small business status can affect fee eligibility.

Health Canada Review Timeline and Deficiency Notices

Once your ALR application and payment are received, Health Canada’s service standard allows up to 120 calendar days for review and processing. After the preliminary review, Health Canada issues invoices for annual licence review applications as part of the administrative process.

If deficiencies are identified during review:

You will receive a deficiency notice by email.
You have two opportunities to submit the missing or corrected information.
Each response restarts the 120-day review clock.
Failure to respond adequately will lead to application rejection and licence cancellation.

Regulatory strategies and regulatory affairs teams should be involved at this stage to ensure compliance and timely responses to Health Canada’s requests.

Fees are non-refundable, even if the licence is later cancelled. Failure to comply with requirements may result in compliance and enforcement actions by Health Canada.

Common Pitfalls in the ALR Application Process

Navigating the Annual Licence Review (ALR) for your Medical Device Establishment Licence (MDEL) can be challenging, especially given the strict requirements set out in the Canadian Medical Devices Regulations. Many MDEL holders encounter common pitfalls that can jeopardize their ability to sell medical devices in Canada.

One frequent issue is submitting incomplete or inaccurate information in the ALR application package. Even minor discrepancies can trigger enforcement actions or delays in the review process. Another common mistake is failing to include all required documentation, such as up-to-date records for complaint handling or recall procedures, which are essential for demonstrating compliance with medical devices regulations.

Missing the ALR submission deadline is another critical error. Health Canada enforces strict timelines, and late submissions can result in immediate licence cancellation, impacting your ability to operate as a medical device establishment. Additionally, some MDEL holders overlook the importance of registering as a small business before submitting their ALR application. Without this status, you may be subject to higher fees, which can be a significant financial burden, especially for those dealing with Class I medical devices or smaller device establishments.

To avoid these pitfalls, ensure your ALR application is complete, accurate, and submitted on time. Double-check your eligibility for small business status and confirm all information aligns with the requirements for your device classes, including Class I medical devices. When in doubt, consult regulatory experts to help navigate the complexities of the annual licence review process and maintain compliance with Canadian medical devices regulations.

MDEL Annual Licence Review Checklist

A thorough checklist is essential for MDEL holders to ensure a smooth and successful Annual Licence Review (ALR) process. Use the following steps to stay organized and compliant with Health Canada’s medical devices regulations:

Verify MDEL Holder Information: Confirm that your establishment address and contact details are current and accurate.
Review Medical Device Listings: Ensure all medical devices, including Class II, III, IV, and IV devices, are correctly listed and classified according to Canadian medical devices regulations.
Confirm Regulatory Compliance: Check that your operations meet all requirements under the Canadian Medical Devices Regulations, including applicable fees and documentation.
Prepare Required Documentation: Gather and update all necessary records, such as complaint handling and recall procedures, to demonstrate compliance.
Pay the Annual Fee: Ensure the annual fee is paid promptly upon issuance of the invoice to avoid delays in the ALR process.
Check ALR Application Package: Carefully review the ALR application package for completeness and accuracy before submission.
Submit on Time: Send your completed ALR application package to Health Canada well before the deadline to prevent enforcement actions or licence cancellation.
Confirm Small Business Status: If you qualify, verify your small business status to benefit from reduced fees. Remember, this status must be renewed annually.
Understand Health Canada’s Role: Familiarize yourself with Health Canada’s expectations and the requirements for maintaining an active MDEL.

By following this checklist, MDEL holders can streamline the ALR process, minimize the risk of errors, and maintain their authorization to sell medical devices in Canada.

Avoiding MDEL Cancellation

To maintain your authorization to conduct licensable activities:

Ensure all ALR documents are accurate and complete.
Submit responses to any deficiency notices before the deadline.
Demonstrate ongoing compliance with GMP standards.
Track communications from Health Canada to avoid missed correspondence.
Assess your establishment’s activities against the MDEL requirement to determine if a medical device establishment license is needed.
Manufacturers must obtain the appropriate medical device license or medical device establishment license based on their manufacture class (e.g., Class I, II, III, IV, including IV medical devices).
Maintain an active licence listing for all devices, including licensed Class II, III and IV medical devices, to ensure ongoing compliance with Health Canada’s regulations.

How Dell Tech Can Support Your MDEL Compliance

Navigating Health Canada’s medical device licensing process can be complex. Dell Tech Laboratories has extensive expertise in navigating Canadian medical device regulations and developing regulatory strategies for health products, ensuring clients meet all requirements for compliance and market access.

At Dell Tech Laboratories, our regulatory experts assist with:

Preparing and submitting Annual Licence Reviews (ALR)
Assisting with annual licence review applications for all device classes, including i devices, and supporting clients in obtaining a Canadian medical device license
Responding to deficiency notices and corrective actions
Maintaining MDEL compliance and GMP readiness
Managing small business status and fee mitigation applications

📞 Contact Dell Tech for expert guidance on your MDEL renewal and to ensure full compliance with Health Canada’s regulatory standa

DELL TECH HAS PROVIDED PROFESSIONAL, CONFIDENTIAL CONSULTING SERVICES TO THE SPECIALTY CHEMICAL INDUSTRY IN CANADA, THE USA, EUROPE AND ASIA FOR THE LAST 40 YEARS.