As a leading provider of medical device regulatory strategy services to innovative MedTech firms BML Health continuously monitors all key announcements and evolving requirements from Health Canada, and other major regulatory agencies worldwide.
For these reasons we are informing MedTech companies presently engaged with Health Canada, or planning to do so in the future, of an important regulatory update that impacts their medical device submissions in Canada.
Introducing the Health Canada Regulatory Enrolment Process (REP) for Medical Devices
Health Canada is introducing significant changes to how companies submit medical device applications and related documents. Starting January 2026, all Class II, III, and IV medical device submissions must be filed using the new Regulatory Enrolment Process (REP) via the Common Electronic Submission Gateway (CESG). Emails will no longer be accepted.
The Regulatory Enrolment Process (REP) for Medical Devices was initially implemented in July 2024 on a voluntary basis, but becomes mandatory as of January 2026. A failure to understand the Regulatory Enrolment Process (REP) and its requirements may lead to delays and setbacks in the submission and approvals process in Canada.
Do you have questions on how the new Health Canada Regulatory Enrolment Process (REP) for Medical Devices impacts your MedTech company?
Contact BML Health today and find out.
What is the Regulatory Enrolment Process (REP)? And what is the Common Electronic Submission Gateway (CESG)?
The Regulatory Enrolment Process (REP) is Health Canada’s new online system for submitting and managing regulatory information. It replaces existing forms with structured web-based templates to streamline submissions. Through REP, the following information may be submitted:
- Company information
- Device and dossier details
- Application information
- Regulatory transactions
The Regulatory Enrolment Process (REP) works together with the Common Electronic Submission Gateway (CESG), a secure portal used to transmit digital submissions directly to Health Canada.
What to Expect Next
Health Canada will be sending a final Company XML file (CO XML) to all active companies in the coming months. This file will contain your current company and contact information, based on Health Canada’s records. Make sure to review the file carefully when you receive it and and get in touch with us to finalize it. Health Canada must be notified of any updates.
If you are a BML Health client and we are your regulatory correspondent on file with Health Canada, we will work closely together with your firm to ensure that the transition to the new Regulatory Enrolment Process (REP) is smooth.
If you are not a BML Health client and you have questions or concerns on how the new Health Canada Regulatory Enrolment Process (REP) will impact your firm, or on any other issue relating to regulatory strategy for medical devices – SaMD, AI/ML, VR/AR, Connected Devices, Cloud Platforms – we invite you to contact us.
BML Health will continue to provide updates and insight about the Health Canada Regulatory Enrolment Process (REP) as they become available and we invite you to keep in touch and contact us if you have any questions on the issue.
About BML Health
We support innovative Medtech companies that are shaping the future of healthcare. BML Health understands the impact of emerging technology in MedTech and Digital Health. Get in touch with us to learn how our iterative, lean and efficient approach to product development, clinical validation and regulatory affairs can help your organization get its MedTech solutions to market and gain adoption.
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