Regulatory Enrolment Process (REP) for Medical Devices Template Revision History

This page outlines changes related to the Regulatory Enrolment Process (REP) templates. Should you have any questions regarding the content of this page, please contact ereview@hc-sc.gc.ca.

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.

December 11, 2024 Release

Template Change
Company Template
Version 4.0.1
  • Translated "Choose file" button on the French template
  • Corrected minor grammatical errors
Regulatory Transaction Template
Version 3.0.1
  • Translated "Choose file" button on the French template
  • Corrected minor grammatical errors
Application Information Template
Version 3.0.1
  • Translated "Choose file" button on the French template
  • Updated the order of error messages for "Interdependent Device Record" and "Declaration of Conformity form"
  • Updated the "Priority Review" section to only appear when "Regulatory Activity Type" is "Licence" or "Licence amendment" and "Device Class" is "III" or "IV"
  • Corrected minor grammatical errors