February 10, 2026

Health Canada is implementing a major modernization in medical device regulatory submissions. Beginning January 2026, manufacturers of Class II, III, and IV medical devices must use the Regulatory Enrolment Process (REP) in combination with the Common Electronic Submission Gateway (CESG) for regulatory filings.

This shift transforms how medical device applications, regulatory transactions, and company information are managed in Canada. For global manufacturers, early preparation is essential to avoid submission delays, technical rejections, and compliance risks.

Maven Regulatory Solutions outlines what this change means and how device companies should prepare.

What Is Health Canada’s Regulatory Enrolment Process (REP)?

The Regulatory Enrolment Process (REP) is Health Canada’s structured digital system designed to standardize and streamline regulatory data collection. REP replaces traditional email-based submissions and static PDF forms with structured web-based templates and XML data elements.

REP supports submission of:

  • Manufacturer and company details
  • Device identification and classification
  • Dossier and application metadata
  • Regulatory transaction tracking
  • Contact and correspondent information

What Is CESG (Common Electronic Submission Gateway)?

The Common Electronic Submission Gateway (CESG) is the secure digital transmission channel used to send structured submissions to Health Canada.

REP and CESG work together:

System

Function

REP

Data entry, structured regulatory information

CESG

Secure electronic transmission of submission package

Who Is Affected?

Starting January 2026, the REP becomes mandatory for:

Device Class

Impact

Class II

License applications & amendments

Class III

New device licenses & significant changes

Class IV

High-risk device submissions

All manufacturers

Regulatory transactions & company data updates

Email-based submissions will no longer be accepted.

Company XML (CO XML) File Requirement

Health Canada is issuing Company XML (CO XML) files to active companies. This file contains:

  • Legal manufacturer information
  • Establishment details
  • Regulatory correspondent data
  • Contact records

Manufacturers must review and update inaccuracies to ensure alignment with REP records.

Why REP Matters for Global Manufacturers

REP aligns with global digital regulatory trends such as:

  • Structured regulatory data exchange
  • Lifecycle regulatory tracking
  • Digital submission ecosystems
  • Metadata-driven Regulatory Review

This improves regulatory transparency, review efficiency, and data consistency.

Risks of Non-Compliance

Failure to transition properly may result in:

  • Submission rejections
  • Licensing delays
  • Incomplete regulatory records
  • Loss of submission priority

Preparation Steps for 2026

Action

Purpose

Audit company data

Ensure accuracy in CO XML

Establish CESG account

Enable secure submissions

Train regulatory teams

REP template navigation

Align dossier structure

Match structured data fields

Update SOPs

Reflect digital submission workflow

2026 Regulatory Trends Related to REP

  • Increased digital regulatory ecosystems
  • AI-supported regulatory review tools
  • Harmonized submission standards
  • Global push toward structured regulatory data

How Maven Regulatory Solutions Supports

Maven helps medical device manufacturers with:

  • REP readiness assessment
  • CO XML review & data validation
  • CESG onboarding support
  • Regulatory data structuring
  • Health Canada license strategy
  • Global submission harmonization

FAQ

Q1: Is REP required for Class I devices?
Primarily focused on Class II–IV licensing and transactions.

Q2: Can submissions still be emailed?
No. CESG transmission becomes mandatory.

Q3: Does REP replace the licensing framework?
No it changes the submission method, not regulatory requirements.