Failure to pay 2021 annual licence review fees will result in cancellation of MDELs

MDEL Bulletin, December 03, 2021, from the Medical Devices Compliance Program

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About the cancellation

In December 2021, Health Canada will cancel medical device establishment licences (MDELs) for licence holders who have outstanding fees for their 2021 annual licence review (ALR) application. You do not need to take any action if you have sent your payment for your 2021 ALR application.

The Fees in Respect of Drugs and Medical Devices Order (Fees Order) states that the ALR fee must be paid for Health Canada to review an application. The authority to withdraw or withhold services in case of non-payment is outlined in the MDEL bulletin Cancellation of MDELs for failure to pay fees. We posted this bulletin on June 24, 2021.

If your establishment licence is cancelled, you are no longer authorized to conduct licensable activities (such as manufacturing, distributing or importing medical devices). You must stop these activities as soon as you receive your cancellation letter.

What cancellation means for licence fees

Health Canada charges fees to examine a licence application. Normally, this fee is charged prior to our review of completed applications. If payment is not received, the application is not reviewed. However, to help meet the demand for medical devices during the COVID-19 pandemic, we did review MDEL applications before collecting fees. As a result, some establishments have had their MDEL application or annual licence review processed and still have an outstanding invoice that has not been paid.

Failure to pay an outstanding invoice will result in the cancellation of your MDEL. If payment is not received, we will send the unpaid invoice to collections.

If you’re unable to pay the MDEL fees for your 2021 ALR application in full due to financial reasons, please communicate directly with accounts receivable at ar-cr@hc-sc.gc.ca. You will be able to discuss the possibility of setting up a payment plan to pay these fees in instalments.

Resuming activities after MDEL cancellation

If your licence is cancelled and you wish to resume licensable activities, you must:

To find out how to re-apply for a MDEL, please refer to our Guidance on medical device establishment licensing (GUI-0016).

If your new licence is issued before April 1, 2022, you will also need to submit an ALR package before April 1, 2022, and pay the applicable fees to renew this licence. This is in accordance with section 46.1(1) of the MDR.

Contact us

If you have questions about a MDEL or the application process, please contact the Medical Device Establishment Licensing Unit at mdel.questions.leim@hc-sc.gc.ca.

If you have questions about invoicing and fees for an MDEL application, please contact the Cost Recovery Invoicing Unit at criu-ufrc@hc-sc.gc.ca.

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