Mandatory use of the regulatory enrolment process for medical devices: Notice to industry
Date: April 24, 2026
On this page
About the mandated process
As of April 1, 2026, manufacturers must use the Common Electronic Submission Gateway (CESG) and the regulatory enrolment process (REP). This mandatory use is part of the Medical Devices Directorate's digital transformation initiative.
The REP collects information from manufacturers on the company, dossiers, devices, regulatory activities and transactions. It consists of a set of web-based templates that generate REP Extensible Markup Language (XML) files upon completion.
To learn more about the REP process:
- watch this webinar and question-and-answer session
- consult the Guidance document on the regulatory enrolment process (REP) for medical devices
What's included
The following types of transactions are affected and all regulatory submissions must be prepared using the International Medical Device Regulators Forum (IMDRF) table of contents format:
- Class II to IV licence applications
- Class II to IV licence amendments
- Class II to IV minor change amendments (faxbacks)
- Class II to IV private label licence applications
- Class II to IV private label licence amendments
- responses to terms and conditions (section 36 of the Medical Device Regulations)
- responses to requests for additional information (section 39 of the Regulations)
- responses to licence suspension (sections 40 and 41 of the Regulations)
What's not included
The following activities are not part of the REP at this time:
- investigational testing applications (ITAs)
- medical device establishment licence (MDEL) applications
- for example, Class I medical devices
- Special Access Program (SAP) applications
- medical devices regulated under Part 1.1 of the Regulations
What you need to do
If you filed an application with our directorate previously, you may already have a final copy of your Company (CO) Template xml. The final CO xml is based on our internal records. You don't need to do anything else if the information listed on your final CO xml is up to date.
If you're a new applicant, you must complete and submit a CO template xml before you can apply for a new medical device licence.
If you need to amend a CO xml, use the web form found on this web page. If your company ID does not currently hold an active medical device licence, indicate this in the Rationale field of the form.
Note:
- All future changes to the company or contact information must be made using this CO xml.
- Regulatory correspondents cannot ask questions about specific regulatory activities or a medical device licence for another company until they complete and submit a separate CO xml.
Contact us
For questions about the CO xml or for a copy of your final CO xml, email us at devicelicensing-homologationinstruments@hc-sc.gc.ca.
For questions about the REP, email us at meddevices-instrumentsmed@hc-sc.gc.ca.