eSTAR Pilot in Canada: A Step Toward Global Submission Harmonization

Medical device regulatory submissions are undergoing a significant structural transformation in Canada. Health Canada’s expanded eSTAR pilot, launched August 2025, and the formal adoption of the IMDRF Table of Contents (ToC) format in November 2025, together mark the most significant shift in how Class II–IV device submissions are prepared and organized in years.

For manufacturers navigating the Canadian market and particularly those pursuing parallel submissions with the FDA understanding both developments is now essential to building an efficient, future-proof submission strategy.

Canada’s eSTAR Pilot: A Notice to Industry

On August 19, 2025, Health Canada officially launched its second expanded pilot program for the electronic Submission Template And Resource (eSTAR). The first Health Canada eSTAR pilot commenced in 2023 with nine participants, all medical device manufacturers, with results shared at the RAPS Regulatory Convergence in 2023 described as favorable. The 2025 iteration built on those lessons, broadening eligibility significantly.

The eSTAR template was originally developed by the U.S. FDA and has been adopted by the IMDRF as a global submission resource. The FDA and Health Canada have been conducting a joint pilot: testing the use of a single eSTAR submitted to both the FDA and Health Canada simultaneously; a landmark step toward true bilateral submission harmonization. Brazil has also referenced the IMDRF ToC as its submission format for medical devices and IVDs, indicating that eSTAR-aligned submissions are becoming a genuinely global standard, not just a bilateral US-Canada initiative.

What Is eSTAR and Why It Matters

eSTAR is a dynamic, intelligent PDF template that guides 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.

A critical November 2025 development strengthens eSTAR’s importance significantly: on November 25, 2025, Health Canada formally issued guidance adopting the IMDRF Table of Contents format for medical device applications across Class II, III, and IV devices, both IVD and non-IVD, as well as private label applications, amendments, and post-market regulatory activities. Health Canada expects that use of the IMDRF ToC will reduce time and costs for both industry and the regulator, ultimately resulting in timely access to medical devices for Canadians.

eSTAR and the IMDRF ToC are directly connected: eSTAR submissions automatically generate output structured to the IMDRF ToC format, and the 2025 pilot specifically tested a conversion tool to adapt eSTAR content into the IMDRF ToC folder structure. Understanding both is now essential for manufacturers preparing Canadian submissions.

The IMDRF ToC Guidance: What Manufacturers Need to Know

The November 25, 2025 IMDRF ToC guidance applies to a broad range of submission types: new license applications, license amendments, post-market submissions, and private label applications for Class II, III, and IV devices.

The guidance is not a legal regulation, it is a formal Health Canada guidance document. This provides some flexibility: alternate dossier structures may be accepted, but only with prior consultation and justification. Deviating without prior agreement risks delays or rejection. In practice, manufacturers should treat the IMDRF ToC as the expected standard for all new submissions.

Key practical requirements include: submissions must follow a defined folder structure with a 200-character path length limit; specific validation rules apply; and free validation tools are available from some regulatory submission software providers; applicants are encouraged to validate their submissions using these tools before filing with Health Canada.

For global companies, the harmonized dossier structure is a significant efficiency gain, it simplifies multi-jurisdiction regulatory submissions and enables templates and guidelines to be reused across markets, reducing errors and improving consistency.

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

The practical file guidance from the eSTAR pilot remains relevant for all structured submissions: keep packages under 1 GB, use compressed formats for media attachments, and combine similar attachments into single files with bookmarks for reviewer navigation.

For IMDRF ToC submissions specifically, additional preparation steps apply: submissions must follow Health Canada’s defined folder structure and validation rules, with a 200-character path length limitation. Applicants are encouraged to use free validation tools available from regulatory submission software providers before submitting to Health Canada. All screening deficiency responses, clarification responses, and additional information responses associated with IMDRF ToC submissions must also follow the ToC structure.

While alternate dossier structures may be accepted with prior consultation and justification, deviating from the IMDRF ToC without prior agreement risks delays or rejection. Teams preparing Canadian submissions should build the IMDRF ToC structure into their standard operating procedures rather than treating it as an optional format.

Additional Aspects: Regulatory Modernization Context

The eSTAR pilot and IMDRF ToC adoption sit within a broader wave of Health Canada regulatory modernization that manufacturers should track alongside submission format changes:

On November 17, 2025, Health Canada proposed Phase II amendments to the Medical Devices Regulations. Key proposed changes include: removing the MDEL requirement for foreign distributors selling through Canadian importers with an MDEL; clarifying that MDEL holders must maintain documented procedures; and requiring all MDEL applicants and license holders to list suppliers of imported or sold devices. The comment deadline was January 17, 2026.

Also in November 2025, Health Canada issued updated guidance on managing applications for medical device licenses, and in March 2026, published the final guidance on how to interpret “significant change” of a medical device for Class III and IV devices.

Taken together, these developments reflect Health Canada’s systematic effort to modernize, harmonize, and digitize the medical device regulatory framework, with eSTAR and the IMDRF ToC as the submission-facing expression of that strategy.

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 strategic benefits of eSTAR and the IMDRF ToC adoption are now more concrete than when the pilot was first announced:

Reduced administrative burden: Health Canada expects the IMDRF ToC to reduce time and costs for both industry and the regulator. Automated validation checks and structured templates reduce deficiencies and administrative back-and-forth.

True harmonization with FDA and IMDRF standards: a single eSTAR submission can now be submitted to both FDA and Health Canada simultaneously, a practical efficiency that was theoretical before the joint pilot confirmed feasibility. For manufacturers pursuing parallel US-Canada market access, this is a significant time and cost saving.

Global submission reuse: Brazil has adopted the IMDRF ToC as its submission format, and the IMDRF RPS Working Group continues to expand its adoption globally. Manufacturers building IMDRF ToC-structured dossiers are investing in submission infrastructure that will be reusable across an expanding set of markets.

Shaping mandatory adoption: The pilot data and manufacturer feedback will directly inform whether Health Canada mandates eSTAR for Class III/IV submissions. Early adopters of the IMDRF ToC format will be ahead of that curve.

Looking Ahead: What’s Next for eSTAR in Canada

The 2025 eSTAR pilot is complete. Health Canada is expected to publish results and lessons learned, monitor the Health Canada medical device announcements page for updates. Based on pilot outcomes and the formal adoption of the IMDRF ToC in November 2025, the trajectory toward mandatory eSTAR use for Class III/IV submissions is clear, though no mandatory timeline has yet been announced.

For manufacturers, the practical implication is immediate: the IMDRF ToC is now the expected standard for Canadian submissions, with deviations requiring prior consultation and justification. Teams that have not yet restructured their submission templates and documentation practices to align with the IMDRF ToC should prioritize doing so now; before a mandatory deadline creates a compliance scramble.

The broader global picture is equally important: as Brazil, Canada, and the FDA all move toward IMDRF ToC-aligned submissions, manufacturers investing in harmonized, structured submission infrastructure today are building a competitive advantage that compounds across every new market entry.

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.

Q&A:

1. Is the Health Canada eSTAR pilot still accepting participants? No. The 2025 eSTAR pilot submission window closed at the end of 2025. The pilot was the second of its kind, the first ran in 2023 with nine participants. Health Canada is expected to publish pilot results and lessons learned. Manufacturers who did not participate can still align with the IMDRF ToC format, which Health Canada formally adopted on November 25, 2025, for all Class II, III, and IV submissions.
2. What is the IMDRF Table of Contents and does it apply to my submissions now? On November 25, 2025, Health Canada issued guidance formally adopting the IMDRF ToC format for medical device applications, including new license applications, amendments, post-market submissions, and private label applications for Class II, III, and IV devices; both IVD and non-IVD. While it is guidance rather than a legal regulation, alternate structures require prior consultation and justification, deviating without agreement risks delays or rejection. In practice, manufacturers should treat it as the expected standard.
3. Can I submit the same eSTAR to both the FDA and Health Canada? Yes, the FDA and Health Canada have been conducting a joint pilot testing the use of a single eSTAR submitted to both regulators simultaneously. This is one of the most significant practical benefits of the eSTAR harmonization initiative for manufacturers pursuing parallel US–Canada market access.
4. Is eSTAR mandatory in Canada? Not yet. eSTAR remains voluntary for Canadian submissions as of May 2026. However, the FDA has made eSTAR compulsory for 510(k) and De Novo submissions in the US, and the formal adoption of the IMDRF ToC in Canada signals a clear direction toward mandatory structured submissions. Manufacturers should align with the IMDRF ToC now to be ahead of any future mandatory requirement.
5. Which device classes does the IMDRF ToC guidance apply to in Canada? The IMDRF ToC guidance applies to Class II, III, and IV devices, both IVD and non-IVD, as well as private label applications, amendments, and post-market regulatory activities.