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 prior to 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 fulfil 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 an [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 that 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 then 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 renewal of the medical device license(s), 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-month period beginning on November 1 of each year. These fees will increase annually to keep up with inflation.
Conclusion
Need help filing your MDL Renewal Form or have questions about the renewal process? Our experts at Quality Smart Solutions would be happy to assist! Please Contact us today or call us at 1-800-396-5144.
References
https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-nformation/guidance-documents/medical-device-licence-renewal-fees-right-sell-licensed-2019/document.html
