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Canada

MDEL vs MDL in Canada: What’s the Difference and Which One Do You Need? 

For any company planning to sell or distribute medical devices in Canada, understanding the country’s licensing framework is essential. Health Canada requires medical device companies to hold the appropriate licences — but two terms often create confusion: MDEL and MDL.  They might sound similar, but these two licences serve very different purposes. Knowing which one applies to your product or business model is the first step to compliance — and to entering the Canadian market smoothly.&n...
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Are You REP-Ready? How to Audit Your Canadian Regulatory Compliance Before 2026 

If you are manufacturing or importing medical devices into Canada—or plan to—you need to be aware of a significant change happening in the regulatory landscape. The Health Canada (“HC”) Regulatory Enrolment Process (REP) is becoming the mandatory electronic framework for device submissions in January 2026.  Being “REP-ready” means more than just familiarizing yourself with templates—it means auditing your entire compliance structure to ensure you don’t have last‐minute surpris...
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Canada Medical Device Registration Process & Classifications

Planning to sell your medical device in Canada?   Health Canada is the government body that reviews and approves all medical devices before they can be marketed in the country. Their goal is simple — to make sure all devices are safe, effective, and high quality.  If you are a manufacturer, importer, or distributor, you must understand how Health Canada classifies medical devices and what kind of licence you need.  At OMC Medical, we help companies like yours register their devices smo...
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eSTAR Pilot program by Health Canada & US FDA

eSTAR (electronic Submission Template and Resource) is an initiative launched by the US Food and Drug Administration in February 2020. It is a free, interactive PDF Form that provides assistance to the applicants in preparing the CDRH medical device submission for 510(k)s and De Novos. The content of the form is automated with an automatic verification feature, and the structure is complementary to the internal review and also harmonized with the IMDRF and guided construction for each submission...
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Health Canada Medical Device Listing

Health Canada is the regulator of therapeutic products, including medical devices. Health Canada’s Medical Devices Active Licencing Listing (MDALL) contains a list of products that are already in the Canadian medical device market. It also contains the database for products that were previously licensed. This article discusses the various information available on MDALL. Read our article on overview of medical device registration in Canada to understand the various license requirements for diff...
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