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Health Canada requires a Medical Device Licence (MDL) for all Class II, III and IV devices before they can be sold in Canada. We help you manage the process end to end, from classification to submission, so you can focus on innovation while we ensure full compliance.
To sell a Class II, III or IV medical device in Canada, manufacturers must obtain a Medical Device Licence (MDL) from Health Canada. This licence verifies that your product meets the required standards for safety, quality, and performance.
Device Classes
Licence Requirements
Renewal & Maintenance
Whether your device needs an MDL, and what that application will require, comes down to classification. Class II, III, and IV devices are reviewed differently, each with its own evidence expectations and level of scrutiny.
Companies that start preparing before classification is settled often find the gap surfaces later, as a request for additional information partway through Health Canada’s review.
Confirming your device class early means building your application around the right pathway from the start. This guide walks through Health Canada’s four device classes, how MDL and MDEL requirements differ, and the decision path to market.
We assess your device’s intended use and technology to confirm its risk class (II, III, or IV) and determine the correct regulatory pathway before submission.
For Class II–IV devices, we verify your ISO 13485 MDSAP certification and ensure alignment with Health Canada’s Medical Devices Regulations (SOR/98-282).
Our experts review your Device Master File, safety and performance data, clinical evidence (if required), and labeling for completeness and compliance.
We compile and validate all required forms, attestations, and supporting evidence to ensure your submission meets Health Canada’s MDL application checklist.
We verify bilingual labeling, safety statements, and UDI details to meet Canadian regulatory standards. We can also review your IFU to ensure compliance with Health Canada regulations.
We handle all communication with Health Canada, addressing information requests and monitoring your application status until approval.
We help you manage annual renewals, amendments, and company updates to maintain ongoing compliance.
Explore the latest articles, blogs, and regulatory news related to Health Canada MDL requirements and medical device licensing.
An MDEL (Medical Device Establishment Licence) allows companies to import or distribute devices, while an MDL authorizes specific devices for sale. Many businesses need both.
No. The manufacturer must be MDSAP certified to apply for an MDL.
Yes. Foreign manufacturers can apply through a Canadian regulatory agent or Importer of Record. We offer both services to help you access the Canadian market efficiently.
Health Canada may require clinical evidence for Class III and IV devices to demonstrate safety and effectiveness. We help assess when it’s needed and how to prepare it.
Incomplete documentation, missing ISO 13485 MDSAP certificates, or insufficient performance data can delay review. We perform a pre-submission review to prevent these issues.
Yes. Your application to Health Canada for a device application must include compliant outer labelling, as well as a compliant IFU document. We can review both items for accuracy.
Health Canada requires annual renewal by December 31. We manage your renewal process and submissions to ensure ongoing compliance.