Cancellation of MDELs for failure to pay fees

MDEL Bulletin, June 24 2021, from the Medical Devices Compliance Program

Fees for Medical Device Establishment Licences (MDELs)

We issue Medical Device Establishment Licences (MDELs) to:

class I manufacturers
importers or distributors of all device classes for human use in Canada

The MDEL fee is a flat fee, regardless of when we receive your initial application. The same fee applies to applications for:

a new MDEL
the reinstatement of a suspended MDEL
the annual licence review (ALR) of an MDEL

If you submit any of these applications, you must pay the MDEL fee when you receive an invoice. See Part 3, Division 2 of the Fees in Respect of Drugs and Medical Devices Order.

Normally, we collect the MDEL fee before we review an application. However, to help meet the demand for medical devices during the COVID-19 pandemic, we have been reviewing and processing MDEL applications before collecting the fees. As a result, some MDEL holders still haven't paid the fees for their 2020 initial MDEL application, despite multiple reminders.

Authority to withhold services in case of non-payment

As stated in the Food and Drug Act, Health Canada has the authority to withhold services, approvals, rights and/or privileges, if the fee for an MDEL application is not paid.

Non-payment of fees

30.64: The Minister may withdraw or withhold a service, the use of a facility, a regulatory process or approval or a product, right or privilege under this Act from any person who fails to pay the fee fixed for it under subsection 30.61(1).

For more information, please refer to:

Cancellation of existing MDELs

We will cancel MDELs for existing MDEL holders with outstanding fees for:

initial applications or
annual licence review applications

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 licensable activities as soon as you receive your cancellation notice.

Resuming activities after MDEL cancellation

To resume licensable activities, you must re-apply for a new establishment licence and pay the MDEL fee. See section 45 of the Medical Device Regulations.

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

In line with the Compliance and Enforcement Policy (POL-0001), Health Canada monitors activities for compliance. If your MDEL has been cancelled, you may be subject to compliance and enforcement actions if you conduct non-compliant activities.

Contact us

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

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

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2021-06-24

Cancellation of MDELs for failure to pay fees

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