Mandatory use of Regulatory Enrolment Process (REP) for medical device applications
2026-09-01 — Mandatory use of Regulatory Enrolment Process (REP) for medical device applications
Health Canada is implementing mandatory use of the Regulatory Enrolment Process (REP), its electronic submission platform, for medical device applications. REP replaces paper-based and legacy electronic submission methods for device licence applications and amendments.
Mandatory REP timelines are being phased in by submission type. Manufacturers and importers holding or applying for Health Canada medical device licences should confirm the current mandatory REP adoption deadline applicable to their submission category on the Health Canada website.
Key actions:
- Register your organisation in the Health Canada REP portal if not already done.
- Ensure your regulatory team has completed REP training.
- Confirm whether your pending or planned submissions must be filed via REP before the applicable deadline.
Verify the exact deadline for your submission type directly with Health Canada, as timelines are subject to revision.
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