Health Canada eSTAR Pilot 2025: Streamlining Class III & IV Submissions

Health Canada has announced the launch of its second eSTAR pilot program, aimed at enhancing the submission process for Class III and IV medical devices, including in vitro diagnostic devices (IVDDs). Building upon the success of the initial pilot, this expanded initiative introduces new features and eligibility criteria to further streamline the regulatory process.

What is eSTAR?

The electronic Submission Template And Resource (eSTAR) is an interactive PDF form developed by the U.S. Food and Drug Administration (FDA). It guides applicants through the process of preparing a comprehensive medical device submission, featuring:

• Automation (e.g., form construction and autofill)

• Content and structure aligned with the International Medical Devices Regulators Forum (IMDRF) Table of Contents

• Integration of multiple resources (e.g., guidances and databases)

• Guided construction for each submission section

• Automatic verification to ensure completeness and compliance

Health Canada Pilot Overview

In 2023, Health Canada initiated a pilot allowing manufacturers to submit eSTAR submissions for certain Class III and IV devices. The feedback was generally positive, demonstrating the feasibility of using eSTAR for Health Canada submissions.

The current pilot expands the scope to include:

• New or significant change amendment applications for Class III and IV devices

• Both IVDDs and non-IVDDs

• Testing of a conversion tool designed to organize content into the IMDRF Table of Contents folder structure

Priority consideration will be given to IVDD applications, which were not included in the previous pilot. A total of 30 participants will be selected based on eligibility criteria.

Eligibility Criteria

To participate in the eSTAR pilot, manufacturers must:

• Be ready to submit a new or significant change amendment Class III or IV submission to Health Canada by the end of the 2025 calendar year

• Ensure the medical device is not a combination product

• Complete the eSTAR (a message at the top of the eSTAR will indicate this)

• Note: Regulatory Enrolment Process (REP) submissions are not accepted at this time

At this stage, only English eSTAR submissions are being accepted; French submissions will follow at a later time.

How to Request Participation

To request participation in the pilot, send an email to meddevices-instrumentsmed@hc-sc.gc.ca with the subject line: "Request for participation in eSTAR – HC pilot."

Include the following information:

• A statement expressing the desire to participate in the Health Canada pilot

• Manufacturer name

• Contact name and title

• Device name

• Preferred name code (PNC) and global medical device nomenclature (GMDN) code related to your device

• A statement confirming that a Class III or IV eSTAR submission will be sent using eSTAR by the end of the 2025 calendar year

• Indicate whether this is a new or significant change amendment application

• Specify whether it is a non-IVDD or IVDD

Health Canada intends to respond to requests within 5 business days.

Preparing a Submission Using eSTAR

If accepted into the pilot, participants will receive an information package containing:

• The eSTAR to use in preparing the submission

• A project plan detailing pilot specifics

• Information on the submission process, including how to use the conversion tool

• A short survey to gather feedback

Participants should be aware of the following constraints regarding attachments:

• File Size: Keep the eSTAR under 1 GB to avoid processing delays

• File Count: Combine attachments of similar content when possible to reduce the number of files

• Format: Ensure attached images and videos are in a Microsoft Windows-compatible format (e.g., JPEG, MP4)

User Fees and Review Timeline

The cost-recovery fees for eSTAR submissions will remain consistent with current fees for the examination of medical device licence applications.

The performance standards for review timelines will also remain the same as those for non-pilot submissions.

Contact Information

For any questions or feedback about the Health Canada eSTAR pilot, please contact the Medical Devices Directorate at meddevices-instrumentsmed@hc-sc.gc.ca.

Internal Links

• CMDR Canada Medical Device Registration & Approval

External Links

• Health Canada eSTAR Pilot Notice to Industry

Health Canada's eSTAR pilot program for 2025 enables manufacturers to submit new or significant change amendment applications for Class III and IV medical devices, including IVDDs, using an interactive PDF form. The pilot introduces a conversion tool for organizing content into the IMDRF Table of Contents structure. A total of 30 participants will be selected based on eligibility criteria. For more details, visit the Health Canada eSTAR Pilot Notice to Industry.

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