What Medical Device Establishment Licence (MDEL) holders need to know about annual licence review for 2023

MDEL Bulletin December 02, 2022, from the Medical Devices Compliance Program

About the annual licence review

To continue doing business, holders of an active medical device establishment licence (MDEL) must apply to have their licence reviewed every year before April 1. This requirement is in section 46.1 of the Medical Devices Regulations (MDR).

Licence holders with a suspended MDEL do not need to apply.

An annual licence review (ALR) ensures that MDEL holders are:

complying with the regulatory requirements
keeping their licence information up-to-date with Health Canada

Health Canada will send the ALR package in December of each year to the establishment contact on file. Please ensure the establishment contact on file is up to date so you can receive your ALR package on time.

To update the contact we have on file, submit a notification application to mdel.application.leim@hc-sc.gc.ca.

You must email your completed ALR application package as soon as possible and before April 1 of each year.

When applicable, please ensure you have a valid small business status before you submit your ALR application.

It's important to submit your ALR application as soon as you have received your ALR package especially if:

you are making amendments within your ALR application
- for example, additions or revisions to the list of manufacturers, change in activity or class of device
you have multiple sites, manufacturers or suppliers listed on your application
- for example, more than 20

As part of your application, a senior official must attest to having certain required procedures in place. This is in accordance with subsections 45(g, h, h.1 and i) of the MDR. As announced in a previous MDEL bulletin, Health Canada posts the names of senior officials to ensure public accountability of an MDEL holder's activities.

A fillable ALR summary report is available in your ALR package. We encourage you to make your revisions and sign the form electronically as we are not able to process any mailed-in application at this time. Email your package to mdel.application.leim@hc-sc.gc.ca.

Changes in the ALR package

We have incorporated the fees checklist into your ALR summary report. Information related to fees and small business is in the email instead of a separate cover letter.

Other changes are as follows.

For sections 4 and 5:

An editable Excel table is now available in your ALR package contains:
- a tab with the list of sites
- a second tab that lists the manufacturers or suppliers associated with your licence
Please make your revisions and include the Excel table with your completed and signed form when submitting your package.

For section 7:

We have included information related to reporting medical device shortages and discontinuations to inform you of:
- your obligations
- our recommendations for reporting shortages

Fees

If you receive your new MDEL before April 1, 2023, you will also need to submit an ALR package before this date. You must also pay the applicable fees when you do so. This is in accordance with section 46.1(1) of the MDR.

We will issue an invoice after we receive and screen your ALR application for completeness. If you do not pay your invoice, we will not process your ALR application and we will cancel your MDEL.

A flat fee is charged for an ALR. The current fee for an MDEL is $4,737. If you qualify as a small business:

you are eligible for a 25% reduction in the fee
the current fee payable for a registered small business is $3,552.75

Small business application

A small business is:

any business, including its affiliates, that has fewer than 100 employees or
has between $30,000 and $5 million (CAD) in annual gross revenues

Applicants must be registered as a small business with Health Canada before they submit their ALR application. You must complete your registration through the Drug and Medical Device Small Business Application portal.

Please note that a company's small business status expires 1 year after registration. If you previously registered as a small business with us and you still meet the definition, you will need to ensure the status is valid or renewed before you submit your ALR application. If your unique identifier has changed since your previous registration, you will also need to register again.

If you no longer hold small business status when submitting your 2023 ALR application, we will issue an invoice for the full fee. Once issued, the invoice for the full fee amount will not be re-visited. It will remain payable regardless of any future changes to your small business status. Please note that the small business registration process can take up to 2 weeks.

For information on how to apply for or renew your small business status, visit the following web page:

Small business mitigation for drugs and medical devices: How to apply for or renew small business status

For questions about your small business status, please email the Small Business Office at sbo-bpe@hc-sc.gc.ca.

Timelines

We process ALR applications in the order we receive them. Our service standard is 120 calendar days to review and process a complete and paid application.

For more information on the completeness of an application, please refer to the MDEL application instructions.

As a courtesy, we send out an ALR application package to all active MDEL holders starting in December every year. If you do not receive your ALR package by mid-January, email us at mdel.questions.leim@hc-sc.gc.ca.

If you do not wish to continue doing business after April 1, 2023, you must indicate this on your ALR package using the cancellation form and we will cancel your licence.

If we do not receive your application before April 1, 2023, we will cancel your licence.

In January 2023, we will post a pre-recorded webinar tutorial on the ALR application process to the GCcollab space. The tutorial is to help stakeholders who may have questions on how to complete their ALR package.

Addressing ALR deficiencies

If your ALR application has deficiencies, we will contact you to correct them. If we do not receive your response to the deficiency notice within the given timeframe or the information is incomplete, we will reject your application and cancel your MDEL. A deficient application does not meet the requirements stated under section 46.1(1) of the MDR.

If your licence is cancelled, you will no longer be authorized to distribute or import your medical device. To resume any licensable activities, you will need to apply for a new MDEL. However, the fees related to processing the ALR application will still be due.

Contact us

For questions about an MDEL and the application process, contact the Medical Device Establishment Licensing Unit by email: mdel.questions.leim@hc-sc.gc.ca.

For questions about invoicing and fees for an MDEL, contact the Cost Recovery Invoicing Unit by email: criu-ufrc@hc-sc.gc.ca.

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Date modified:: 2022-12-02

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