The Health Canada eSTAR pilot program

On this page

• About eSTAR
• Joint pilot between Health Canada and FDA
• Health Canada-only 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
• Contact us

About eSTAR

eSTAR is an interactive PDF form 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 match the following:
• internal templates used by the Center for Devices and Radiological Health (CDRH)
• the Non-In Vitro Diagnostic Device Market Authorization Table of Contents document used 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

Joint pilot between Health Canada and FDA

Health Canada and the U.S. Food and Drug Administration (FDA) are conducting a joint pilot. The pilot will test the use of a single eSTAR submitted to both Health Canada and the FDA. The feasibility of using eSTAR will be determined by the outcome of a pilot with 9 participants. They will use the non-In Vitro Diagnostic eSTAR, which follows the structure of the IMDRF Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nIVD MA ToC).

For more information on this joint pilot, please see the Health Canada and FDA eSTAR pilot: Notice to industry.

Health Canada-only pilot

Health Canada is also launching our own pilot that will enable medical device manufacturers to submit an eSTAR submission for a new or significant change amendment for a Class III or IV application. For this pilot, 10 participants who meet the following criteria will be chosen to participate.

Depending on demand, we may not be able to choose every manufacturer who has indicated interest. We will inform applicants by email if they have been chosen 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 within 6 months of acceptance
• the medical device must not be an in vitro diagnostic device (IVDD) and/or 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 Pilot – HC only pilot".

Include the following information in your email:

• a statement asking to take part in the Health Canada-only pilot
• manufacturer name
• contact name and title
• device name
• preferred name code (PNC) and global medical device nomenclature (GMDN) of your device
• a statement that a Class III or IV eSTAR submission will be sent to us using eSTAR within 6 months of acceptance
• indicate if this is a new or significant change amendment application

We will respond to your request within 5 business days.

Preparing a submission using eSTAR

If Health Canada accepts you into the 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

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 not within the scope of this pilot. Please submit these as per the instructions on the request.

User fees for eSTAR pilot

There will be cost-recovery fees for eSTAR submissions. For current cost-recovery fee amounts, please refer to the following:

• Fees for the examination of an application for a medical device licence

Review timeline for eSTAR 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-only pilot, please contact the Medical Devices Directorate by email at meddevices-instrumentsmed@hc-sc.gc.ca.