Canada Licences (MDL & MDEL)
Health Canada Compliance
for medical devices
Access the Canadian market with confidence.
Canada Licences (MDL & MDEL)
To sell medical devices in Canada, manufacturers must comply with the Medical Devices Regulations (SOR/98-282) under the Food and Drugs Act. The regulatory pathway depends on the device class and on the role of the company involved in manufacturing, importing or distributing the device.
For Class I devices, a Medical Device Establishment Licence (MDEL) is required and may be held by the manufacturer, importer or distributor. For Class II, III and IV devices, a Medical Device Licence (MDL) issued by Health Canada is required, in addition to an MDEL for the establishment involved in distribution or import.
ALTRION provides comprehensive support for MDEL Canada and Medical Device Licence Canada pathways, helping manufacturers, importers and distributors manage classification, licensing, renewals and post-market compliance. All establishments and manufacturers must operate under a Quality Management System compliant with ISO 13485, preferably certified under the Medical Device Single Audit Program (MDSAP).
Canadian medical device regulatory pathway
The first step for Canadian market access is understanding the correct regulatory pathway. ALTRION supports companies in determining whether a device requires an MDEL, an MDL or both, based on the device class and the company’s role in the supply chain. This assessment helps manufacturers, importers and distributors avoid regulatory uncertainty and prepare the right documentation before placing medical devices on the Canadian market.
Device classification
Device classification is essential because it determines the applicable licensing requirements. ALTRION assists with device classification and the definition of the regulatory pathway for Class I, II, III and IV medical devices. Class I devices generally require an MDEL, while Class II, III and IV devices require an MDL issued by Health Canada. Correct classification helps define the level of documentation, quality system requirements and submission strategy needed for compliance.
MDL applications for Class II, III and IV devices
For Class II, III and IV devices, manufacturers must obtain a Medical Device Licence from Health Canada before selling the device in Canada. ALTRION supports the preparation and submission of MDL applications, helping manufacturers organize the required information and manage the licensing process. This support is designed to make the Medical Device Licence Canada pathway clearer, more structured and aligned with Health Canada expectations.
MDEL registration for manufacturers, distributors and importers
The Medical Device Establishment Licence is required for certain manufacturers, importers and distributors involved in the sale, importation or distribution of medical devices in Canada. ALTRION supports MDEL registration for Class I devices and for establishments involved with higher-class devices where required. This includes helping companies understand whether they need an MDEL, preparing the relevant information and supporting the registration process.
ISO 13485 and MDSAP compliance
All establishments and manufacturers must operate under a Quality Management System compliant with ISO 13485, preferably certified under MDSAP. ALTRION supports companies in aligning their quality system with ISO 13485 and MDSAP expectations, helping them strengthen regulatory readiness for Canadian medical device compliance. This is particularly important for manufacturers of Class II, III and IV devices, where quality system requirements are closely connected to the licensing process.
Licence renewal, post-market surveillance and incident reporting
Canadian medical device compliance does not end once the licence is obtained. Companies must maintain their licences, manage renewals and continue monitoring device performance after market entry. ALTRION supports licence renewal, post-market surveillance and incident reporting activities, helping manufacturers and establishments maintain ongoing compliance with Health Canada requirements. This support helps companies keep their regulatory status active and respond properly to post-market obligations.
Representation for non-Canadian manufacturers
Non-Canadian manufacturers may need local support to manage communication, representation and regulatory processes in Canada. ALTRION supports representation for non-Canadian manufacturers through collaboration with qualified Canadian partners and local representatives. This helps international companies manage the Canadian regulatory pathway with clearer communication and better coordination during licensing and post-market activities.
Direct interface with Health Canada
Communication with Health Canada is an important part of the licensing process. ALTRION provides support as a direct interface with Health Canada, helping manage official communications, submission follow-up and regulatory questions. This service is useful for companies that need structured support during MDEL registration, MDL applications, renewals or post-market compliance activities.
FAQ about MDEL Canada and Medical Device Licence Canada
What is an MDEL in Canada?
An MDEL, or Medical Device Establishment Licence, is a licence required for certain manufacturers, importers and distributors involved in selling, importing or distributing medical devices in Canada. For Class I devices, an MDEL is generally required.
What is a Medical Device Licence in Canada?
A Medical Device Licence, or MDL, is issued by Health Canada for Class II, III and IV medical devices. It authorizes the sale of a specific medical device in Canada, provided the applicable regulatory requirements are met.
What is the difference between MDEL and MDL?
An MDEL applies to the establishment involved in manufacturing, importing or distributing medical devices. An MDL applies to the medical device itself and is required for Class II, III and IV devices.
Do Class I medical devices need an MDEL?
Yes. Class I devices generally require a Medical Device Establishment Licence held by the manufacturer, importer or distributor involved in selling the device in Canada.
Is ISO 13485 required for medical devices in Canada?
Manufacturers and establishments must operate under a Quality Management System compliant with ISO 13485, preferably certified under the Medical Device Single Audit Program (MDSAP), depending on the regulatory pathway and device class.
Why choose ALTRION
ALTRION supports companies with in-depth knowledge of the licensing process and the review of MDLs by Health Canada. Through collaboration with qualified Canadian partners and local representatives, ALTRION helps manufacturers, importers and distributors manage the Canadian regulatory pathway with clearer procedures and more predictable approval times. Its support covers both device licences and establishment licences, giving companies a complete approach to MDEL Canada and Medical Device Licence Canada compliance.
Deliverables
ALTRION provides practical regulatory outputs to support Canadian market access and ongoing compliance.
- Validated MDL and/or MDEL licence numbers.
- Submission log and official Health Canada communications.
- Annual renewal assistance and vigilance reporting.
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