The ALR application due date for MDELs is April 1, 2023. If you hold a Medical Device Establishment Licence (MDEL), you must submit your completed ALR application before April 1. While the process of submitting an ALR application has not changed, the fees have.
New Fees for Annual Licence Renewal (ALR) Applications
The fees for ALR Applications have risen 6.8% year over year to $5,060 in 2023 from $4,737 in 2022.
What is Required in Your Annual Licence Review Application?
Health Canada has provided the following steps in order to renew your MDEL
- Name and address of the establishment
- Name, title, and phone number of the representative of the medical device
- A statement affirming whether the medical devices are being imported or distributed
- The medical specialties of the device being imported or distributed
- An attestation by a senior official that the establishment has policies and procedures in place for distribution records, complaint handling, and recalls
- If the establishment imports Class I medical devices, an attestation by a senior official that the establishment has policies and procedures in place for reporting under subsection 59(1) and (1.1)
- If the establishment imports Class II, III, or IV medical devices, an attestation by a senior official that the establishment has policies and procedures in place for reporting under subsection 59(1) and the provision of information under section 61.2.
- If the establishment imports or distributes Class II, III, or IV medical devices, an attestation by a senior official that the establishment has policies and procedures in place for handling, storage, delivery, installation, corrective action, and servicing of their medical devices
- The address of each building for the policies and procedures described in paragraphs 6, 7, and 8
What To Do if You Have Not Received Your ALR Application Package
The Annual Licence Renewal application packages are sent out to MDEL holders starting in December every year. If you have not received it yet, email Health Canada directly at firstname.lastname@example.org
What Happens if You Do Not Submit Your ALR Application
Health Canada will cancel your licence if they do not receive your application by April 1, 2023
How To Submit
Health Canada recommends submitting your ALR applications electronically to: email@example.com
If you have any questions about your ALR or need assistance applying for an MDEL, or a canceled or suspended licence, contact dicentra today.