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.

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January 28, 2026 release

Template Change
Company (CO)
template
version 5.0.0

Stylesheet package*
  • Added info bubble for the company template
  • Updated error messages for various fields
  • Added pop-up warnings for various buttons
  • Updated button labels for amending company representative information
  • Corrected minor grammatical errors


  • *New CO stylesheet to match changes on this template
Regulatory
transaction (RT)
template
version 4.0.0

Stylesheet package*
  • Added info bubble for the regulatory transaction template
  • Updated error messages for various fields
  • Added regulatory activity types: Section 39/40/41 and Terms and conditions (section 36)
  • Removed regulatory activity type: S.25/36/39/40/41
  • Added transaction descriptions: Extension request, Request for reconsideration, Request for review reports, Response to opportunity to be heard letter and Response to reconsideration information request
  • Removed transaction descriptions: Appeal Comprehensive Document, Letter of Intent to Appeal, Response to s.25 Letter and Response to s.36 Letter
  • Corrected minor grammatical errors


  • *New RT stylesheet to match changes on this template

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