As of April 2026, Health Canada has implemented the Regulatory Enrolment Process (REP) as the mandatory submission pathway for medical device licence applications and related regulatory transactions.
REP for medical devices submission
REP facilitates the filing and processing of regulatory information related to medical devices and their manufacturers through web-based templates that capture data in a structured format. These templates replace existing application and fee forms previously used by Health Canada.
Submissions are transmitted via the Common Electronic Submissions Gateway (CESG), Health Canada’s secure electronic gateway for regulatory filings. The use of CESG aligns Canada with the United States regulatory practices, as it is also used by the US Food and Drug Administration (FDA) for electronic submissions. While the technical gateway is similar, submission formats and regulatory requirements remain specific to each jurisdiction.
REP applies to both Medical Device Licences and Medical Device Establishment Licences applications.
Medical Device Licences (MDL): regulatory requirement and scope
Before a medical device can be placed on the Canadian market, manufacturers must obtain a Medical Device Licence (MDL) from Health Canada. This licence is device-specific. An MDL is required for Class II, III, and IV medical devices, ensuring that the device complies with the Canadian Medical Devices Regulations and that its benefits outweigh its risks.
The documentation required for an MDL application varies depending on the device class:
- Class II devices: administrative information, device details, labelling, and a valid MDSAP quality management system certificate
- Class III and IV devices: In addition to the documentation required for Class II devices, Health Canada requires a comprehensive technical dossier, including evidence of safety and effectiveness
Medical Device Establishment Licences (MDEL): economic operators requirements
As of April 2026, applications for Medical Device Establishment Licences (MDELs) must also be submitted through the REP.
An MDEL is required for companies that import or distribute medical devices in Canada, as well as for Class I manufacturers marketing their products directly in the Canadian territory. For example, foreign manufacturers of Class I devices that sell directly into Canada without a Canadian importer must obtain an MDEL.
For any questions on medical devices’ compliance in Canada, contact us here!
References
Government of Canada. (2026). Filling submissions electronically. Retrieved on 21/04/2026.
Government of Canada. (2026). Medical device licencing. Retrieved on 21/04/2026.
Government of Canada. (2026). Regulatory enrolment process (REP) for medical devices. Retrieved on 21/04/2026.
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