Health Canada Medical Device License Renewals (MDL or MDEL) in 2023

As a Canadian medical device license (MDL) holder, you are subject to an annual license renewal procedure. The renewal process has two purposes, the first is to verify that the MDL will remain active and will continue to be sold in Canada. The second reason is to collect and analyze the appropriate information before invoicing for the right to sell fee.

Process 

The renewal process involves manufacturers of medical devices that are licensed for sale in Canada, to inform Health Canada each year before November 1st, that the information on their license has not changed. Health Canada will send each manufacturer who is marketing a licensed class II, III, or IV medical device an annual license renewal package in early August. This package will allow the manufacturer to fulfill their regulatory obligation and contains the Renewal Form with instructions. The Renewal Form contains the following information:

• Regulatory correspondence address of the manufacturer
• Name of the regulatory correspondent and their contact information
• Attestation page
• Section 43 of the MDR
• Name of the manufacturer
• A listing of all the manufacturer’s licensed devices, their license number, and class that are currently on the market

Instructions 

Health Canada has provided the following instructions for the completion of the Renewal form:

• Correct any changes to the name of the contact person or their contact information in the space provided to the right of the contact information
• A senior official of the Manufacturer or their designated regulatory correspondent must sign the attestation
• Indicate medical device licenses that should be discontinued by placing a [X] beside the medical device license number in the discontinue column. This means that the manufacturer has stopped marketing the device or family of devices in Canada
• If all the products for which medical device licenses are listed are to remain on the Canadian market, place an [X] in the appropriate column

Failure to Comply 

Please be advised, that any changes to the MDL other than changes to contact information and notification of discontinuation will not be accepted via the Renewal Form. All other changes must be addressed by submitting the appropriate amendment form to Health Canada. The Renewal Form is required to be emailed to the Bureau of Device Licensing Services Division of the Medical Devices Directorate before November 1 of the year it is received license_renewal@hc-sc.gc.ca. Failure to renew by the November 1st deadline may result in the cancellation of existing medical device licenses by the Medical Devices Directorate.  

Invoicing and Payment

Renewal applications are processed on receipt. Therefore, invoices are mailed in December for payment within 30 days. The invoice documentation confirms the renewal of the medical device license(s), and describes the license(s) and the associated fee(s). 

Additional Fee Information 

Health Canada carries out post-market monitoring and assessment of medical devices. The fee for the right to sell a licensed medical device is used to pay for a portion of these activities. The fee is charged annually for the twelve months beginning on November 1 of each year. These fees will increase annually to keep up with inflation. 

MDELs must submit their ALR applications by April 1, 2023. If you possess a Medical Device Establishment Licence (MDEL), your ALR registration must be submitted in its entirety by April 1st. The fees have changed, but the procedure for filing an ALR application has not.

New Fees for Applications for Annual License Renewal (ALR):

The cost of an ALR application has increased by 6.8% from $4,737 in 2022 to $5,060 in 2023.

What is required in your annual MDEL Licence Review Application?

Health Canada has provided the following steps in order to renew your MDEL

1. Name and address of the establishment
2. Name, title, and phone number of the representative of the medical device
3. A statement affirming whether the medical devices are being imported or distributed
4. The medical specialties of the device being imported or distributed
5. An attestation by a senior official that the establishment has policies and procedures in place for distribution records, complaint handling, and recalls
6. If the establishment imports Class I medical devices, an attestation by a senior official that the establishment has policies and procedures in place for reporting under subsection 59(1) and (1.1)
7. If the establishment imports Class II, III, or IV medical devices, an attestation by a senior official that the establishment has policies and procedures in place for reporting under subsection 59(1) and the provision of information under section 61.2.
8. If the establishment imports or distributes Class II, III, or IV medical devices, an attestation by a senior official that the establishment has policies and procedures in place for handling, storage, delivery, installation, corrective action, and servicing of their medical devices
9. The address of each building for the policies and procedures described in paragraphs 6, 7, and 8.

Conclusion 

Need help filing your MDL Renewal Form or have questions about the renewal process? To learn about the process for renewing all other medical device licenses i.e. the Medical Device Establishment License (MDEL) or about MDEL Listings Our experts at Quality Smart Solutions would be happy to assist! Please contact us today or call us at 1-800-396-5144.