Health Canada Announces Second Pilot of Medical Device Licenses and Use of eSTAR

By Ken Pilgrim, Sarah Fitzgerald and Evangeline Loh

Background on IMDRF and US FDA eSTAR

The International Medical Device Regulators Forum (IMDRF) Working Group (WG) on Regulated Product Submission (RPS) continues to revise guidance on the Table of Contents (ToC) guidance. In addition, the WG committed to adopting the U.S. Food and Drug Administration (FDA) electronic Submission Template Resource (eSTAR) as a global resource.

The U.S. FDA has continued to revise eSTAR and make it compulsory for 510(k)s and de novo submissions. 

First Health Canada eSTAR pilot

The first Health Canada eSTAR pilot commenced in 2023 with nine participants, all medical device manufacturers. Results shared at the RAPS Regulatory Convergence in 2023 were favorable. While one participant dropped out, two participants had already secured 510(k) clearance and Medical Device License (MDL) authorization. 

Health Canada states, “Feedback from pilot participants was generally positive, and demonstrated proof of concept for the eSTAR template to be used for Health Canada submissions.”

Second Health Canada eSTAR pilot

Health Canada (August 2025) has announced its second pilot of eSTAR for Class III and Class IV MDLs, covering either new or significant change amendment applications. The pilot is intended to include 30 participants, prioritizing in vitro diagnostic (IVD) devices. Participants need to email Health Canada to request participation, include the details specified in the announcement and be ready to submit the MDL by the end of 2025. In addition to eSTAR, the announcement states that participants will also “test the conversion tool designed to convert content into the IMDRF Table of Contents folder structure.”

Concluding remarks

This is another exciting step in the work of the IMDRF RPS WG, as well as the pilot of eSTAR outside the U.S. Recall that in Brazil, the resolutions for medical devices and IVDs referenced the IMDRF ToC as the submission format as well. 

Emergo by UL continues to monitor global regulatory developments.