Regulatory Enrolment Process (REP) for Medical Devices
In order to access the most up-to-date version of the template, please be reminded to delete your cache frequently and “refresh” the template links on your web browser prior to each use
REP Template & Form Links
Outside the Regulatory Transaction Process
Company (CO) Template (2024-12-11)
- Required to obtain a company ID and/or provide updated company information to Health Canada.
-
Sent via the email.
- Attach draft CO XML file to email prior to sending.
- Refer to section “2.3 Company Enrolment/Amendments Process” of the REP guidance document for Medical Devices.
Dossier ID Request Form for Medical Devices
- Required to obtain a Dossier ID.
- Refer to section “2.4 Dossier ID Request Process” of the REP guidance document for Medical Devices.
Within the Regulatory Transaction Process
Regulatory Transaction Template (2024-12-11)
- Required with each regulatory transaction filed to Health Canada.
- Refer to section “2.5 Application Process” of the REP guidance document for Medical Devices.
Application Information Template (2024-12-11)
- Required for only a subset of transactions. Refer to section “2.5.2 Application information (AI) Template and Process” of the REP Guidance Document for Medical Devices.
Device Details (2023-12-01)
- Required for all new licence applications, as well as any amendment applications that may impact a manufacturers catalogue listing.
- Download Device Details xlsx file.
Application Attestation Form (2024-01-15)
- Required for the initial transaction of a new regulatory activity
- Download Application Attestation pdf form.