Regulatory Enrolment Process (REP) for Medical Devices
REP Template & Form Links
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Outside the Regulatory Transaction Process
Company Template (July 31, 2024)
- 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 the REP guidance document for Medical Devices for detailed descriptions of the requirements for the company template.
Dossier ID Request Form for Medical Devices
- Required to obtain a Dossier ID.
- Upon completion, the form is auto-sent via email to Health Canada.
Within the Regulatory Transaction Process
Regulatory Transaction Template (July 31, 2024)
- Sent via the CESG within the regulatory transaction (application).
- Required with each regulatory transaction filed to Health Canada.
- Refer to the REP guidance document for Medical Devices for detailed descriptions of the requirements for the RT template.
Application Information Template (July 31, 2024)
- Sent via the CESG within the regulatory transaction (application).
- 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 detailed description of the requirements for the AI template.
Device Details (December 1, 2023)
- Sent via the CESG within the regulatory transaction (application).
- 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 (January 15, 2024)
- Sent via the CESG within the regulatory transaction (application).
- Required for the initial transaction of a new regulatory activity
- Download Application Attestation pdf form.