The eSTAR pilot: Notice to industry
On this page
- About eSTAR
- Health Canada pilot
- Eligibility factors for the eSTAR pilot
- Requesting participation in the eSTAR pilot
- Preparing a submission using eSTAR
- Submitting responses to requests for additional information
- User fees for eSTAR pilot
- Review timeline for eSTAR pilot applications
- Contact us
About eSTAR
The electronic Submission Template And Resource (eSTAR) is an interactive PDF form developed by the United States Food and Drug Administration (U.S. FDA) that guides applicants through the process of preparing a comprehensive medical device submission. The template contains the following features:
- Automation (for example, form construction and autofill).
- Content and structure that matches the In Vitro Diagnostic Medical Device Regulatory Submission Table of Contents (Edition 4) and the Non-In Vitro Diagnostic Device Regulatory Submission Table of Contents (Edition 4) documents developed by the International Medical Devices Regulators Forum (IMDRF).
- Integration of multiple resources (for example, guidances and databases).
- Guided construction for each submission section.
- Automatic verification.
- Guides the applicant to help ensure they provide the necessary details for the submission.
- Serves as a comprehensive resource to consolidate the necessary information and links needed for submission preparation.
Health Canada pilot
In 2023 Health Canada launched a pilot to enable manufacturers to submit an eSTAR submission for certain Class III and Class IV submission types. We also conducted a joint pilot with the U.S. FDA. Feedback from pilot participants was generally positive, and demonstrated proof of concept for the eSTAR template to be used for Health Canada submissions.
Health Canada is launching a second pilot that expands the scope of submission types. Under this pilot, medical device manufacturers can submit an eSTAR submission for either a new or significant change amendment application for a Class III or IV device, including both in vitro diagnostic devices (IVDDs) and non-in vitro diagnostic devices (non-IVDDs). As part of the pilot, participants will also test the conversion tool designed to convert content into the IMDRF Table of Contents folder structure. Priority consideration will be given to IVDD applications as they were not in scope of the previous pilot. For this pilot, 30 participants who meet the eligibility factors will be selected.
Depending on demand, we may not be able to include every manufacturer who has indicated interest. We will inform applicants by email if they have been selected for the pilot.
We encourage manufacturers to submit their requests for participation as soon as possible.
Eligibility factors for the eSTAR pilot
To be eligible to participate in this pilot:
- you 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
- the medical device must not be a combination product
- you must complete the eSTAR (a message at the top of the eSTAR will indicate this)
We are not accepting regulatory enrolment process (REP) submissions.
At this time, we are only accepting English eSTAR submissions. French eSTAR submissions will follow at a later time.
Requesting participation in the eSTAR pilot
To request participation in the pilot, send an email to meddevices-instrumentsmed@hc-sc.gc.ca. In the subject line put "Request for participation in eSTAR – HC pilot".
Include the following information in your email:
- a statement asking to take part 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 that a Class III or IV eSTAR submission will be sent to us using eSTAR by the end of the 2025 calendar year
- indicate if this is a new or significant change amendment application
- specify whether it is a non-IVDD or IVDD
We intend to respond to your request within 5 business days.
Preparing a submission using eSTAR
If Health Canada accepts you into the eSTAR pilot, we will provide you with an information package that includes:
- the eSTAR to use in preparing your submission
- the project plan, including details about the pilot
- information on the submission process, including how to use the conversion tool
- a short survey to gather your feedback
Please note the following constraints regarding the size and count of attachments added to eSTAR.
File size
- Try to keep the eSTAR under 1 GB in size (may take longer to process the submission if it's larger than this).
- Make sure that attached images and videos are compressed in a Microsoft Windows-compatible format viewable in native Windows OS applications (for example, JPEG, MP4).
- Provide ultra-high-definition videos only if high resolution is necessary to support the review of the device.
- Take care when determining the proper resolution to display features of interest in images and videos.
File count
- Combine attachments of similar content (for example, software requirements specifications) when possible so that only 1 attachment needs to be provided to each attachment type question in the eSTAR.
- Choose "Tools" then "Combine Files" in Adobe Acrobat Pro to combine attachments.
- Use bookmarks or a table of contents for combined documents, to make it easier to review.
Submitting responses to requests for additional information
Responses to requests for additional information are within the scope of this pilot. Please submit these as per the instructions on the request.
User fees for eSTAR pilot
Cost-recovery fees for eSTAR submissions will be the same as the current cost-recovery fee amounts:
Review timeline for eSTAR pilot applications
The performance standards will remain the same as they are for non-pilot submissions.
Contact us
For any questions and/or feedback about the Health Canada pilot, please contact the Medical Devices Directorate by email at meddevices-instrumentsmed@hc-sc.gc.ca.