The Health Canada eSTAR pilot program

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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:

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:

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:

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:

Please note the following constraints regarding the size and count of attachments added to eSTAR.

File size

File count

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:

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.

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