By: Ivy Tang, PRINCIPAL REGULATORY CONSULTANT, email
In the realm of medical device safety, effectiveness, and quality, Canada has some of the strictest regulatory requirements. One of the key aspects of our regulatory system is the Annual Licence Review (ALR) process, which is applicable to both medical device licences (MDL) and medical device establishment licences (MDEL). This article will focus on the ALR process for MDLs. The purpose of this ALR is twofold: first, to confirm whether a (MDL) will remain active, thus allowing the continuation of sale; second, to collect the necessary information prior to invoicing the annual fee.
Medical Device Licence Annual Renewal
In early August of every year, manufacturers of licensed Class II, III, and IV medical devices in Canada will receive an ALR package from Health Canada. To remain in compliance with Section 43 of the Medical Devices Regulations, the renewal and attestation forms must be completed and returned to Health Canada before November 1. Failure to do so will result in the cancellation of the medical device licence(s) and prohibition of sale. If this occurs, a new MDL application must be submitted along with all applicable fees.
The ALR process allows the manufacturer to confirm their contact information, mitigation status (if applicable), currently active MDLs, as well as to indicate which MDLs should be discontinued. Note that MDLs issued between July 27 and November 1 will not be included on the ALR form as they are automatically renewed; however, a renewal fee will still apply.
Except for changes to contact information, amendments such as a class change, manufacturer name change, or device name change are not allowed during the ALR process. These amendments must be submitted to Health Canada using an appropriate amendment form.
Annual Licence Review (ALR) Processing Timeline
Renewal applications are processed as soon as they are received. After the application is processed, an invoice confirming the MDL renewal(s) and associated fees will be mailed in December, with payment due within 30 days. Health Canada will then update their database (Medical Devices Active Licence Listing, or MDALL) accordingly.
Renewals and Medical Device Licence Acquisition – How we can help
Annual licence reviews are a cornerstone of medical device regulations. Dell Tech Laboratories offers medical device regulatory and quality services, ensuring your products are compliant for the Canadian market. Contact us today for assistance with annual renewals, obtaining Medical Device Licence and Medical Device Establishment Licence applications, risk classification (both in Vitro Diagnostic Devices and non-in Vitro Diagnostic Devices), Quality Management System support, label reviews, Medical Device Single Audit Program (MDSAP) readiness (formerly CMDCAS- Canadian Medical Devices Conformity Assessment System), and more. For additional information, reach out to our team!
Interested in learning more about medical devices? Read our recent post on Medical Device Regulations Amendment.
Dell Tech has provided professional, confidential consulting services to the specialty chemical
industry in Canada, the USA, Europe, and Asia for the last 40 years.
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