Health Canada REP and CESG: Mandatory Digital Submissions for Medical Device Licences (Class II–IV), IMDRF ToC Format, XML Templates, and the New Submission Workflow Effective April 2026

What Changed: Health Canada's Digital Transformation for Medical Device Submissions

On April 1, 2026, Health Canada's Medical Devices Directorate formally mandated the use of the Regulatory Enrolment Process (REP) and the Common Electronic Submissions Gateway (CESG) for all Class II, III, and IV medical device licence (MDL) applications and related regulatory transactions. A formal Notice to Industry published on April 24, 2026 confirmed the transition and outlined the scope of affected submissions.

This is not a gradual phase-in. PDF application forms and email submissions are no longer accepted for covered transaction types. Manufacturers who have not transitioned to REP will face application delays, technical rejections, and potential disruptions to their Canadian market access.

The REP was first made available on a voluntary basis in July 2024, following a multi-year pilot. Health Canada used the voluntary period to refine the system, address manufacturer feedback, and build internal processing capacity. The April 2026 mandate applies to the full scope of Class II–IV device licensing activities.

Key Parameters

REP Architecture: How the System Works

The REP is a structured electronic submission framework that replaces traditional application forms with web-based templates. These templates generate Extensible Markup Language (XML) files containing structured information about the manufacturer, its devices, and the regulatory activity being filed.

The Four REP Templates

The REP consists of four web-based templates that manufacturers must use:

These templates replace the following legacy forms:

• Class II, III, and IV new licence application forms
• Licence amendment application forms
• Minor change (faxback) forms
• Private label licence application forms

If a manufacturer files a legacy PDF form alongside a REP XML file, the transaction may be rejected.

The CESG: Secure Submission Gateway

The Common Electronic Submissions Gateway (CESG) is the secure electronic portal through which all REP-generated submissions are transmitted to Health Canada. Manufacturers must have an active CESG account before filing any regulatory transaction. The CESG provides:

• Secure, encrypted transmission of submission packages
• Acknowledgment of receipt
• Tracking of submission status

REP and CESG work together: REP handles data entry and XML file generation, while CESG handles secure transmission. Neither system changes the underlying regulatory requirements for device licensing — they change only the submission method.

The Three-Step Filing Process

Step 1: Company Enrolment

Before any regulatory transaction can be filed, the manufacturer must complete the Company (CO) Template and obtain a Company ID from Health Canada. This is the foundational step.

For manufacturers with existing MDLs: Health Canada has pre-populated CO XML files based on its internal records. Manufacturers should request their final CO XML and verify that all company information is accurate. Any changes must be submitted using the CO template — not by contacting Health Canada directly.

For new applicants: Complete and submit the CO template before applying for any medical device licence.

Critical rule: All future changes to company or contact information must be made using the CO XML template. Regulatory correspondents cannot ask questions about specific regulatory activities or licences for another company until they have completed and submitted a separate CO XML.

Step 2: Dossier ID Request

Each device or device family requires a unique Dossier ID. If the manufacturer already has a Dossier ID from prior submissions, it carries forward. If not, the manufacturer must complete and submit a Dossier ID Request Form.

Health Canada validates the information submitted on the request form, populates its internal systems, and issues the Dossier ID to the manufacturer via email.

Step 3: Filing a Regulatory Transaction

With an up-to-date CO XML and a valid Dossier ID, the manufacturer can file regulatory transactions using the RT and AI templates. The complete submission package — including REP XML files and the technical dossier in IMDRF ToC format — is transmitted via CESG.

The filing workflow:

1. Complete the RT template (identifies transaction type)
2. Complete the AI template (provides device-specific application details)
3. Generate final REP XML files from the templates
4. Package XML files with the technical dossier in IMDRF ToC format
5. Transmit the complete package via CESG
6. Receive acknowledgment from Health Canada

What Submissions Are Affected

Mandatory REP Transactions

The following regulatory activities must be filed using REP and CESG:

• New medical device licence applications (Class II, III, and IV)
• Licence amendments (significant and minor changes)
• Minor change amendments (faxbacks)
• Private label licence applications and amendments
• Responses to terms and conditions
• Responses to requests for additional information
• Responses related to licence suspensions

What's Not Included

The following submission types are excluded from the REP mandate:

• Investigational testing applications (ITAs)
• Medical device establishment licence (MDEL) applications
• Special Access Program (SAP) applications
• Medical devices regulated under Part 1.1 of the Regulations
• Class I device applications (Class I devices are not subject to MDL requirements)

The IMDRF Table of Contents Format

As of April 1, 2026, Health Canada also requires that all applicable medical device submissions be organized using the International Medical Device Regulators Forum (IMDRF) Table of Contents (ToC) format. This requirement was published in Health Canada's guidance on November 25, 2025, incorporating IMDRF N9 and N13 Edition 4.

The IMDRF ToC format standardizes the structure of technical dossiers across participating regulatory authorities, enabling:

• More efficient review by Health Canada reviewers
• Alignment with submissions to other IMDRF members (FDA, TGA, MHLW/PMDA, etc.)
• Reduced manufacturer burden when filing in multiple jurisdictions
• Improved traceability and completeness of technical documentation

Manufacturers should ensure that their technical documentation is already structured in IMDRF ToC format before initiating a REP submission. Reformatting an existing dossier to comply with IMDRF ToC can take significant time for companies not already using this structure.

Practical Implications for Global Medical Device Manufacturers

If You Already Have an Active MDL

You do not need to re-apply, but you must:

1. Request your final CO XML from Health Canada and verify its accuracy
2. Confirm your Dossier ID for each existing device or device family
3. Transition your internal regulatory filing processes to REP/CESG for any future amendments, renewals, or new applications
4. Train your regulatory affairs team on the XML template workflow

If You Are a New Applicant

You must complete the full three-step REP process before filing any licence application:

1. Complete and submit the CO template to obtain a Company ID
2. Request a Dossier ID for each device family
3. Prepare your technical dossier in IMDRF ToC format
4. File via CESG using the RT and AI templates

Plan for additional lead time in your first REP submission. Health Canada's validation of the CO template and issuance of the Dossier ID can take several business days.

If You Use a Regulatory Representative

Regulatory representatives (third-party consultants or in-country representatives) can file on behalf of manufacturers, but they must have their own CESG account and must complete a separate CO XML. The representative's CO XML links them to the manufacturer's company information.

Internal Process Changes Required

For most manufacturers, the REP mandate requires updating internal workflows:

• Regulatory affairs teams must learn the XML template system
• Document control processes must produce IMDRF ToC-structured dossiers
• IT systems must support CESG account management and XML file generation
• Quality systems should be updated to reference REP/CESG in regulatory filing procedures
• Training records should document team competency with the new submission process

Key Differences from the Previous Process

Related Health Canada Regulatory Changes in 2026

The REP mandate is part of a broader set of regulatory changes affecting medical device manufacturers in Canada:

Guidance on Managing Applications for Medical Device Licences (Effective February 2, 2026)

This guidance document introduced:

• Streamlined reconsideration process (reduced to a single level of appeal)
• Introduction of Additional Information – Noncompliance (AI-N) letters
• Updated filing requirements aligned with REP

Guidance on Machine Learning-Enabled Medical Devices (MLMD)

Health Canada published pre-market guidance for machine learning-enabled medical devices in 2026, establishing classification and evidence requirements for AI/ML-based devices in the Canadian market. This is particularly relevant for manufacturers of adaptive algorithm-based devices that also need to comply with REP filing requirements.

COVID-19 Testing Device Reclassification

Health Canada revised the risk classification of COVID-19 testing devices, which had been classified as Class IV due to the high transmission risk of SARS-CoV-2. The reclassification ensures regulatory oversight remains proportional to the current risk profile.

Proposed Regulatory Amendments for MDEL Holders

Published in November 2025, proposed amendments would introduce:

• Risk-based approach to licensing distributors outside Canada
• MDEL requirement to provide supplier lists
• Explicit requirements for MDEL holders to implement and maintain standard operating procedures

Frequently Asked Questions

Is REP required for Class I devices?

No. The REP mandate applies to Class II, III, and IV medical device licence applications. Class I devices are not subject to MDL requirements and fall under separate MDEL provisions.

Can I still submit by email?

No. For all covered transaction types, CESG transmission is mandatory. Email submissions will not be accepted.

Does REP change the regulatory requirements for my device?

No. REP changes the submission method, not the underlying regulatory requirements. The safety and effectiveness evidence required for your device class remains the same.

What happens if I submit a PDF form instead of REP XML?

The transaction may be rejected. REP XML files supersede the information in legacy forms. If both are submitted together, the transaction will likely be returned.

How long does the CO template validation take?

Health Canada does not publish specific timelines for CO template validation. Manufacturers should allow several business days and plan accordingly for their first submission.

Do I need a separate CESG account for each device?

No. One CESG account per legal entity is sufficient. Multiple Dossier IDs can be managed under a single CESG account.

My company already has active MDLs. What do I need to do?

Request your final CO XML from Health Canada, verify its accuracy, and ensure your team is trained on REP/CESG. You do not need to re-apply for existing licences, but all future amendments and new applications must use REP.