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RQS Blog

Health Canada Launches eSTAR Pilot for IVD Submissions

5 Things to Know About Health Canada's New eSTAR Pilot for IVD Submissions

 

Health Canada has officially launched a new pilot program allowing medical device manufacturers to use the FDA’s electronic Submission Template and Resource (eSTAR) for In Vitro Diagnostic Device (IVD) submissions. This marks a major step toward harmonizing submission processes across regulatory agencies and streamlining the pathway for market authorization in Canada.

 

1. Pilot Program Leverages FDA-Built Submission Template: eSTAR

The FDA-developed electronic Submission Template and Resource (eSTAR) is an interactive PDF designed to simplify medical device submissions. It guides manufacturers through each required section, integrates relevant resources, and includes built-in verification to help ensure completeness. 

For IVD manufacturers, this means fewer errors, more consistent formatting, and stronger alignment with international submission standards.

 

2. IVDs Take Center Stage in Health Canada’s Latest Pilot

Health Canada’s first eSTAR pilot in 2023 focused on Class III and IV non-IVD devices. With this new program, IVDs are now included, making it possible to submit both new applications and significant change amendments for Class III and IV devices. Priority will be given to IVD applications since they were not eligible in the previous pilot.

 

3. Who Qualifies for the Pilot Program?

To take part of Health Canada's second eSTAR pilot, manufacturers must me the following eligibility thresholds:

  • Be ready to submit a new or significant change amendment Class III or IV application by the end of 2025
  • Ensure the device is not a combination product
  • Complete the eSTAR form in English (French submissions will follow later)

Health Canada plans to accept 30 participants into the program, with priority consideration for IVD manufacturers.

 

4. Why IVD Companies Should Consider Participating in the Pilot Program

The eSTAR pilot offers multiple advantages to IVD manufacturers:

 Consistency with FDA submissions – easing dual-market strategies

Streamlined preparation – fewer formatting errors and missing information

Harmonization with IMDRF standards – supporting global regulatory alignment

 Faster, more efficient reviews – submissions are easier for regulators to navigate

 

5. What Participants Can Expect Next

Selected participants can expect to recieve:

  • The official eSTAR template for Health Canada submissions
  • Guidance on using the conversion tool that formats applications into the IMDRF Table of Contents structure
  • A project plan and process instructions
  • A feedback survey to help refine the program

Review timelines and cost-recovery fees will remain the same as traditional submissions.

 

Health Canada's Strategic Move Towards Global Harmonization 

For IVD manufacturers looking to expand into Canada, the eSTAR pilot represents a significant opportunity to streamline submissions, reduce regulatory burden, and align with international best practices. With Health Canada and the FDA moving toward greater harmonization, companies that adopt eSTAR early will be better positioned for global success.

 

Need Help Preparing Your IVD Submission Using eSTAR?

Rook Quality Systems has hands-on experience with FDA eSTAR submissions and can help guide your strategy for Health Canada’s new pilot. Contact us today to get expert support for your next application.



 

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