What MDEL holders need to know about the annual licence review for 2021

MDEL Bulletin December 15 2020, from the Medical Devices Compliance Program

About the annual licence review

To continue doing business, holders with an active medical device establishment licence (MDEL) must apply for an annual licence review (ALR) every year before April 1. This requirement is in section 46.1 of the Medical Devices Regulations. Licence holders with a suspended MDEL don’t need to apply.

An ALR ensures that MDEL holders are:

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

You must email your completed ALR application package before April 1 of each year. We are not able to process any mailed-in application forms at this time because of COVID-19 measures in place. We encourage you to submit your application early, any time after January 1, 2021, especially if your company deals with a significant number of manufacturers.

Fees

We will invoice you for the annual fee even if there are no changes to your licence. Be sure to pay this fee as soon as you receive the invoice. The fee is updated annually by an amount equivalent to the Consumer Price Index from the previous year, beginning on April 1, 2021.

If you qualify as a small business, you are eligible for a 25% reduction in the fee. Make sure your company registers and has small business status before submitting your application.

A small business is any business that has:

fewer than 100 employees or
between $30,000 and $5 million Canadian in annual gross revenue

As of April 1, 2020, Health Canada is no longer:

deferring fees for applicants that have not completed their first full calendar year of MDEL activities
remitting full or partial fees for applicants based on gross revenue generated from MDEL activities

We will, however:

offer a reduced rate (25%) for small businesses
waive fees for applications filed by any branch or agency of the Government of Canada or of a province or territory
credit 25% of the fee if an applicable performance standard is not met

Timelines

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

As a courtesy, Health Canada sends out an ALR application package to all active MDEL holders at the end of December every year. If you do not receive your ALR package by mid-January, email us at hc.mdel.questions.leim.sc@canada.ca.

If you do not wish to continue doing business after April 1, 2021, please indicate this on your ALR package and we will cancel your licence.

If we do not receive your application before April 1 of each year, we will cancel your licence. If your licence is cancelled, you will no longer be authorized to conduct licensable activities such as manufacturing, distributing or importing medical devices. To resume any licensable activities, you will need to apply for a new MDEL.

Contact us

For questions about a medical device establishment licence (MDEL) and the application process, contact the Medical Device Establishment Licensing Unit by email: hc.mdel.questions.leim.sc@canada.ca.

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

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Date modified:: 2020-12-15

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