eSTAR Pilot in Canada: A Step Toward Global Submission Harmonization

Traditional medical software has been built on static models, validated once and unchanged in production. AI/ML systems, however, are increasingly continuously learning, adapting to new data post-deployment.

While this enhances performance and personalization, it also introduces regulatory risk: changing model behavior can alter safety and efficacy. Regulators now need frameworks that accommodate evolving intelligence, not just snapshot validation.

The new generation of AI-driven tools are continuously learning and adapting to new data long after deployment. This shift introduces enormous promise for improving clinical outcomes but also challenges the long-standing regulatory model of “approve once and monitor occasionally.”

Canada’s eSTAR Pilot: A Notice to Industry

On August 19, 2025, Health Canada officially launched its expanded pilot program for the electronic Submission Template And Resource (eSTAR), a structured, interactive PDF template originally developed by the U.S. FDA under IMDRF initiatives. This initiative marks a significant step toward digital harmonization in medical device regulatory submissions. 

The eSTAR template not only streamlines the submission process but enhances consistency, accuracy, and regulatory alignment internationally.

What Is eSTAR and Why It Matters

eSTAR is a dynamic, intelligent PDF template crafted to guide applicants through preparing comprehensive medical device submissions. Benefits include automated form building, autofill functionality, built-in content following IMDRF-standardized Tables of Contents, embedded guidances and databases, step-by-step submission guidance, and automatic verification checks to reduce deficiencies. 

This streamlined, semi-automated format helps ensure that submissions are complete and formatted as expected by reviewers, cutting down on administrative back-and-forth and aligning closely with both Health Canada and U.S. FDA requirements.

Expanding the Pilot: What’s New in 2025

Health Canada’s newest pilot broadens eligibility, inviting manufacturers to participate voluntarily for new or significant change amendment submissions for Class III and Class IV devices, covering both in vitro diagnostic devices (IVDDs) and non-IVDDs. Unlike the prior pilot, this iteration introduces a conversion tool to adapt eSTAR content into the IMDRF Table of Contents folder structure. 

While priority may be given to IVDD submissions (previously excluded) only 30 participants will be selected based on eligibility factors and readiness. Importantly, devices must not be combination products, and only English-language eSTAR submissions are accepted at this time; French-language submissions are planned for rollout later.

How to Participate in the Pilot

Manufacturers interested in joining the pilot must prepare and submit:

• An email to [meddevices-instrumentsmed@hc-sc.gc.ca] with subject line: “Request for participation in eSTAR – HC pilot.”
• Details including manufacturer name, contact person, device trade name, corresponding PNC and GMDN codes, confirmation of a Class III/IV submission by end of 2025, whether it’s new or a significant change, and whether the device is IVDD or non-IVDD. 

Health Canada aims to respond within five business days, confirming acceptance and sharing an information package that includes the eSTAR template, project plan details, conversion tool instructions, and a short feedback survey for participants.

Preparing Your Submission: Practical Considerations

Once accepted into the pilot, applicants receive an info package and must watch for file constraints:

• File size guidance: Keep the eSTAR package under 1 GB, larger files may lead to processing delays. Media attachments like images or videos should be in compressed formats (e.g., JPEG, MP4), with ultra-high-definition content only included when absolutely necessary.
• Attachment management: Combine attachments of similar content into a single file (e.g., software specs), using tools like Adobe Acrobat Pro’s “Combine Files.” Include bookmarks or a table of contents to make navigation easier for reviewers.

Additional Aspects of the Pilot

• Responses to information requests: If Health Canada asks for additional information, those responses must follow the individual instructions provided (they are not submitted via eSTAR as part of the pilot).
• User fees and timelines: Fees remain the same as for standard submissions, and pilot submissions will adhere to the same review timelines as non-pilot counterparts.

Strategic Benefits for Industry

The eSTAR pilot brings several clear advantages to medical device sponsors:

1. Reduced administrative burden and improved submission accuracy thanks to automation and built-in validations.
2. Harmonization with FDA and IMDRF standards, aligning Canada’s process with international regulators.
3. Potential for more efficient reviews and fewer information requests.
4. Learning and influencing future policy , as Health Canada evaluates pilot outcomes and may mandate eSTAR for Class III/IV submissions in the future.

Looking Ahead: What’s Next for eSTAR in Canada

The pilot is planned  until the end of 2025, after which Health Canada will publish results and share lessons learned. Based on pilot success and feedback, eSTAR could become a mandatory format for high-risk device submissions, further embedding digital convergence in global regulatory frameworks.

Conclusion: Why This Matters and What to Do Next

Health Canada’s expanded eSTAR pilot is a critical step toward digital modernization and international alignment in medical device regulation. By simplifying submission preparation, driving consistency, and offering a pathway to mandatory adoption, eSTAR positions Canada at the forefront of interoperable, efficient regulatory processes.

For manufacturers preparing Class III or IV submissions before the end of 2025, now is the time to act: request participation, shape the pilot’s outcome, and gain valuable early insights into Canada’s evolving submission landscape.