[Home](/)/[Resources](/resources)/Canada Medical Device Licensing CanadaGlobalRegulation guide # Canada Medical Device Licensing Health Canada licenses medical devices under a four-tier risk classification (Class I–IV), with device licensing and an ISO 13485-certified quality system required for the higher-risk classes. Once issued, a Medical Device Licence and its holder appear in MDALL — Health Canada's free, live public registry, useful both for your own compliance record and for checking competitor licence status. Copy Link[Share on WhatsApp](https://wa.me/?text=https%3A%2F%2Fkrono-labs.com%2Fguides%2Fcanada-medical-device-licensing) At a glance Regulator Health Canada Classes I, II, III, IV QMS requirement ISO 13485 Public registry MDALL ## Classification and licensing structure ### Class I — lowest risk Low-risk devices where establishment licensing (not device licensing) is typically the operative requirement, subject to Health Canada's current classification guidance for the specific device type. ### Class II, III, IV — increasing risk These classes require a Medical Device Licence issued by Health Canada before sale, with the depth of clinical and technical evidence required scaling with risk class. ### ISO 13485 quality system A certified ISO 13485 quality management system is a standard prerequisite for device licensing at the classes that require it — this needs to be in place before, not after, the licence application is submitted. ### MDALL public registry The Medical Devices Active Licence Listing is Health Canada's free, live, public search tool at health-products.canada.ca/mdall-limh/, supporting both Active Licence and Archived Licence searches by company name/ID, licence name/number, device name, or device identifier. ## Licensing workflow 01 Determine the device's risk classification (I, II, III, or IV) under Health Canada's medical device classification rules. 02 Establish or confirm an ISO 13485-certified quality management system appropriate to the classification. 03 Prepare the device licence application dossier — technical documentation, evidence of safety and effectiveness, and QMS certification. 04 Submit the application to Health Canada for regulatory review. 05 Receive the Medical Device Licence (MDL) once review is satisfactorily complete. 06 Confirm the device appears correctly in the public MDALL listing. 07 Import and distribute — market access follows licence issuance, with post-market obligations (adverse event reporting, licence maintenance) continuing afterward. ## Frequently asked questions ### Can I check whether a competitor's device already holds a Canadian licence? Yes — MDALL is a free, public tool. Search by company name or ID, licence name or number, device name, or device identifier to see Active or Archived licence status for any registered device. ### Is ISO 13485 certification required for every device class? It's a standard requirement for the classes needing a device licence (generally II–IV), scaled to the specific classification and device type. Confirm the exact QMS expectation for your device's classification with current Health Canada guidance rather than assuming a blanket rule across all classes. ### Does a Health Canada device licence cover sale in every province? Yes — medical device licensing is federal, unlike electrical product safety, which is provincial in Canada. A Health Canada Medical Device Licence is valid for sale nationwide once issued. ### Is there a special access pathway outside standard licensing? Yes. Health Canada maintains special access pathways for exceptional circumstances outside the standard licensing route — these are narrow exceptions, not an alternative general-purpose route, and standard device licensing remains the default expectation for commercial sale. **Disclaimer:** Educational resource only. Regulatory requirements change and vary by product category. Consult an accredited test laboratory or qualified compliance engineer before making certification decisions. 🇨🇦 Canada roadmap for your product Every standard, document, and test that applies — free, no account required. See your free roadmap[ Want an expert to take your product through 🇨🇦 Canada compliance for you? One consultant from Krono's compliance team takes your product from requirements to legal sale, with a fixed quote before any work starts. See compliance services](/services) Learn this properly In-depth course that teaches the full process, not just this one answer. 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