Regulatory enrolment process (REP) for medical devices
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REP template & form links
Outside the regulatory transaction process
Company (CO) template (2026-01-28)
- Required to obtain a company ID and/or provide updated company information to Health Canada.
- Sent by email.
- Attach draft CO XML file to email prior to sending.
- Refer to section “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 “Dossier ID request process” of the REP guidance document for medical devices.
Within the regulatory transaction process
Regulatory transaction template (2026-01-28)
- Required with each regulatory transaction filed to Health Canada.
- Refer to section “Application process” of the REP guidance document for medical devices.
Application information template (2026-03-25)
- Required for only a subset of transactions. Refer to section “Application information (AI) template and process” of the REP guidance document for medical devices.
Device details (2026-03-25)
- 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 (2026-03-25)
- Required for the initial transaction of a new regulatory activity
- Download application attestation pdf form