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We help your business secure and maintain a valid Medical Device Establishment Licence (MDEL) from Health Canada. Our team guides you through every step, from application preparation to renewals, in collaboration with trusted specialists who ensure your compliance framework meets regulatory expectations.
Before medical devices can be imported or distributed in Canada, establishments must hold a valid MDEL issued by Health Canada. This licence confirms that your company maintains the required procedures for complaint handling, recalls, recordkeeping, and post-market activities.
At Quality Smart Solutions, we simplify this process by ensuring your MDEL application or renewal is complete, compliant, and accurately reflects your business activities. In collaboration with trusted regulatory specialists, we help you build a solid foundation for compliance so you can confidently operate and grow in the Canadian market.
We help you prepare and submit your MDEL application to Health Canada, ensuring every section is accurate, compliant, and well-documented. Our team also handles correspondence and responds to Health Canada’s follow-up questions efficiently.
In collaboration with trusted specialists, we develop and review your Standard Operating Procedures (SOPs) to ensure your establishment meets Health Canada’s expectations for complaint handling, recalls, and distribution controls.
If your business qualifies as a small establishment, we help prepare and submit the fee reduction application form to minimize your registration costs.
Once licensed, we can conduct routine audits of your MDEL activities, review updates to your SOPs, and confirm that your documentation remains aligned with Health Canada’s Medical Devices Regulations (SOR/98-282).
We help you complete and submit your Annual Licence Review (ALR) package before the April 1 renewal deadline. Our team verifies all supporting documentation, confirms if any business activities have changed, and ensures your submission meets Health Canada’s standards to avoid refusals.
We assess your establishment profile to confirm that listed products remain active and compliant for the Canadian market, preventing the risk of outdated or invalid listings.
We act as your point of contact with Health Canada, managing communication, addressing information requests, and ensuring your establishment maintains good regulatory standing year-round.
Who Needs an MDEL
Any company that imports or distributes Class I–IV medical devices in Canada must hold an MDEL, unless exempt under Section 44 of the Medical Devices Regulations.
MDEL vs MDL
An MDEL is issued to establishments, while an MDL authorizes specific medical devices. Many businesses require both licences to operate legally.
Renewal Process
Licence holders must renew their MDEL every year by submitting an Annual Licence Review (ALR) before April 1. Failure to renew can result in suspension or cancellation.
Compliance Obligations
Licence holders must maintain records of distribution, recalls, and complaint handling. Health Canada may audit establishments at any time to verify compliance.
Explore our most recent articles, blogs, and videos covering Health Canada MDEL requirements, compliance updates, and best practices for medical device establishments.
An MDEL authorizes establishments to import or distribute medical devices, while an MDL authorizes specific devices for sale. Many companies require both licences.
Any establishment that imports or distributes medical devices (Class I–IV) in Canada must hold an MDEL, unless it’s a healthcare facility or a manufacturer selling directly to end users.
Health Canada’s service standard for reviewing MDEL applications is typically 120 calendar days, though actual timelines may vary depending on submission completeness.
Licence holders must submit an attestation by April 1 each year to maintain their licence. We manage this process to ensure continued compliance.
If you miss the April 1 deadline, Health Canada may cancel your MDEL. You would then need to re-apply as a new applicant, which can delay your operations.
Yes. Foreign companies that distribute or import into Canada can obtain an MDEL through a Canadian regulatory representative such as Quality Smart Solutions.
Yes. Health Canada performs routine and for-cause inspections to verify that establishments comply with quality, recordkeeping, and recall requirements.
Yes. However, you must be prepared for an audit. The location must follow safe storage and SOP practices.
No. You must pay the full annual fee regardless of when you apply.
No. You must include all suppliers and device numbers in your MDEL application.