Health Canada Made Electronic REP and CESG Filing Mandatory for Device Licences in 2026

Health Canada’s notice to industry states that, as of 1 April 2026, manufacturers must use the Common Electronic Submission Gateway (CESG) and the Regulatory Enrolment Process (REP) for medical device regulatory activities. The notice presents the change as part of the Medical Devices Directorate’s digital transformation initiative. Law firm and industry summaries report that the notice was released on 24 April 2026, after the effective date, and that it confirmed the 1 April date.

REP is Health Canada’s structured enrolment system. It collects company, dossier, device and transaction information through web-based templates that accompany the regulatory submission. CESG is the electronic gateway through which the submission is transmitted to Health Canada. Health Canada’s REP page lists version 4.0.1 of the regulatory transaction template as the current version for medical devices.

The notice also states that submissions must follow the International Medical Device Regulators Forum (IMDRF) table of contents format. Because the IMDRF table of contents is an internationally developed structure, using it may reduce reformatting for manufacturers that prepare device submissions in the same format for other jurisdictions.

Secondary summaries describe the mandatory requirement as applying to new medical device licence applications and licence amendment applications for Class II, III and IV devices, together with other application-related regulatory transactions. One law firm summary notes that, subject to some exceptions, most device regulatory submissions must now use REP and CESG.

The exceptions reported include investigational testing applications, medical device establishment licence (MDEL) applications and Special Access Program applications, which are not yet part of REP. Class I devices do not require a device licence and are therefore outside the licence application process. Sources differ on the treatment of devices under Part 1.1 of the Medical Devices Regulations, so manufacturers of those devices should confirm their position with Health Canada.

Some third-party websites state that the requirement took effect in January 2026. The official Health Canada notice and several law firm and industry summaries give 1 April 2026, which should be treated as the effective date. Manufacturers that are unsure whether a particular filing made in early 2026 met the requirement can check the date and scope in the official notice.

For drugs, REP is already established. Health Canada’s drug REP page states that REP applies to the eCTD format only and that, depending on the regulatory activity type, eCTD may be either the mandatory or the recommended format. The 2026 device notice does not change drug requirements. Drug sponsors therefore continue to follow the existing REP and eCTD guidance for drug products, and the device notice should not be read as introducing new obligations for drug or biologic submissions.

Health Canada’s plans for eCTD v4.0 are less clear. Consultancy publications give different timelines, with some reporting optional v4.0 submissions from 2026 and mandatory use around 2028, and others projecting voluntary acceptance from 2027 and a requirement from 2029. A Health Canada document setting out a v4.0 timetable was not found in the sources reviewed for this brief, and sponsors should rely only on dates Health Canada publishes.

Manufacturers that have not yet filed through REP need a CESG account and familiarity with the REP templates before their next licence application or amendment. Submissions should be organised to the IMDRF table of contents, and regulatory teams should check that they are using the current template version listed on Health Canada’s REP page.

Separately, Health Canada is modernising medical device establishment licensing. A compliance bulletin of 30 October 2026 states that the MDEL application can now be submitted only online and gives 1 December 2026 as the date on which amended establishment licensing regulations take effect, correcting an earlier date of 14 December 2026. Companies that hold both device licences and establishment licences should track both changes, because they follow different processes.

Foreign manufacturers that rely on Canadian regulatory consultants or importers to file on their behalf should confirm who holds the CESG account and how REP templates will be maintained across successive transactions. Because REP collects company and device information in structured templates for each transaction, inconsistent entries between filings can create avoidable queries. A single owner for REP data within each company, with a record of what was submitted in each transaction, reduces that risk.