Health Canada released a notice to industry on April 24, 2026, outlining that manufacturers must use the Regulatory Enrolment Process (REP) and Common Electronic Submission Gateway (CESG) for medical device transactions as of April 1, 2026. As we previously reported, manufacturers of medical devices could voluntarily use the REP and CESG for medical device regulatory transactions as of July 2024. The REP is used by Health Canada to collect information from manufacturers on their company, dossiers, devices, regulatory activity and regulatory transactions.
The REP includes web-based templates that facilitate filing regulatory information. These templates generate REP Extensible markup language (XML) files upon completion. These files are sent to Health Canada using the CESG, which is a secure electronic submissions platform.
Subject to some exceptions (e.g., investigational testing applications, medical device establishment licence (MDEL) applications), most regulatory submissions must now use the REP and CESG.
Health Canada published Guidance on the regulatory enrolment process for medical devices on April 1, 2026.
Health Canada also updated the following guidance documents to include information on using the REP for specific regulatory transactions:
- Guidance on how to complete the application for a new or amended medical device licence
- Guidance on how to complete the application for a new medical device licence or amendment for a private label medical device
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.