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Health Canada Medical Device License (MDL) and MDEL Registration

ANSWERED ON THIS PAGE:

  • Which medical devices require a Canada Medical Device Establishment Licence?
  • Which medical devices require a Canada Medical Device Licence?
  • What are the QMS requirements for each licence type?

If you are planning on selling medical devices in Canada, you will most likely need to register your product by securing a license. There are two types of licenses issued by Health Canada with different requirements.

Health Canada Medical Device Establishment License (MDEL)

If you manufacture Class I medical devices or IVDs and plan to sell directly into Canada without a distributor, you must secure a Medical Device Establishment License (MDEL). If you choose to sell through distributors in Canada, your distributor is required to have an MDEL. Medical device distributors and importers must secure an MDEL regardless of device classifications.

Health Canada Medical Device License (MDL)

The Canadian Medical Device License (MDL) is required for companies selling Class II, III, or IV medical devices in Canada. The MDL is a product approval, while a MDEL is a permit for the company/distributor/importer itself.

Canada's Medical Devices License (MDL) is comparable to the US FDA 510(k) process. The process of securing an MDL is usually faster that a 510(k) for Class II devices, about the same for Class III devices, and more complicated for Class IV devices.

Health Canada Medical Device and Quality Management System Requirements

When applying for a Canadian Medical Device License, you will also need to prove that you have a certified ISO 13485 quality management system that also meets the specific requirements of the Canadian Medical Devices Regulations (CMDR). You can read more about ISO 13485 for Canada here.

How Emergo can help with Health Canada medical device approval

With offices in British Columbia and Ontario, Emergo has experience helping 100+ medical device and IVD companies enter the Canadian market. Our services include:

  • Confirming your device classification in Canada. See the Health Canada process chart for details.
  • Completing and filing the Canadian Medical Device License (MDL) or Medical Device Establishment License (MDEL) application on your behalf.
  • Developing, implementing or modifying your ISO 13485 quality management system to meet Canadian requirements.
  • Providing onsite employee training on ISO 13485 and Canadian Medical Devices Regulations (CMDR).
  • Determining the proper annual license fee payable to Health Canada.
  • Providing onsite auditing to confirm compliance with ISO 13485:2003 and CMDR.

Contact us for more information on our Health Canada medical device registration services.

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Common questions

My device has FDA clearance – is there a fast-track for devices sold in other major markets?
Health Canada does not recognize approvals in other countries and they do not give you an advantage in the approval process. However, a rejection of an application in another jurisdiction may adversely affect an approval in Canada.

Much of the information required for Health Canada submission is the same as that of an EU technical file or US 510(k), so having these could potentially reduce preparation time.

Do foreign manufacturers need in-country representation in Canada?
No. In-country representation is not required by Health Canada for medical devices. Foreign manufacturers may submit device registration applications and hold the registration.

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