Health Canada has expanded the scope of its electronic Submission Template And Resource (eSTAR) pilot, giving medical device manufacturers a new pathway for Class III and IV device submissions.
What is eSTAR?
eSTAR is an interactive PDF submission template developed by the U.S. FDA to standardize and streamline medical device applications. The tool guides applicants through required sections, automates certain inputs, integrates resources, and verifies formatting before submission. The FDA made eSTAR mandatory for most device submissions in October 2023, and Health Canada has been piloting the approach since 2023.
Expansion of the Canadian Pilot
Health Canada’s pilot, first launched last year, is now in its second phase with an expanded scope. Key updates include:
- Eligible submissions: Class III and IV medical devices, including both in vitro diagnostic devices (IVDDs) and non-IVDDs.
- Conversion tool testing: Participants will trial a tool that converts submissions into IMDRF-compliant folder structures, aligning Canadian requirements with international formats.
- Language availability: Currently, submissions must use the English version of the eSTAR form. A French version will follow.
Eligibility for Participation
Manufacturers may apply to join the pilot if they:
- Plan to submit a new application or significant change amendment for a Class III or IV device before the end of 2025.
- Confirm the device is not a combination product.
- Complete and submit the eSTAR template in English.
Applications to participate should be sent to meddevices-instrumentsmed@hc-sc.gc.ca with the subject line: Request for participation in eSTAR – HC pilot. Details required include manufacturer information, device type, submission classification (IVDD or non-IVDD), and submission category.
Submission and Review Standards
- Submissions must remain under 1 GB, with compressed images or videos in Windows-compatible formats.
- Similar attachments should be combined, and bookmarks used for reviewer navigation.
- Fees and timelines remain unchanged: user fees are identical to standard submissions, and review timelines follow Health Canada’s established performance standards.
Why This Matters
This expansion signals Health Canada’s intent to align more closely with FDA and IMDRF submission practices, reducing administrative burden and moving toward global harmonization of device submissions. For manufacturers preparing Class III and IV device applications in Canada, adopting eSTAR early can ease future regulatory transitions and ensure smoother interactions with both Health Canada and FDA requirements.
Visit the official Health Canada notice for full guidance.
If you are preparing a Class III or IV device submission in Canada or planning for upcoming MDR/IVDR requirements in Europe, schedule a call with our experts to discuss how these updates impact your regulatory strategy.
