Need Regulatory Help? Try Our Platform
Post your regulatory questions or request quotations from verified pharmaceutical consultants worldwide. Get matched with experts who specialize in your market.
January 14, 2026
Approximately 5 minutes
Health Canada – FDA eSTAR Pilot Program for Medical Device Submissions
Health Canada – FDA eSTAR Pilot Program for Medical Device Submissions
Program Overview and Objectives
In 2023, Health Canada and the United States Food and Drug Administration (FDA) initiated a voluntary pilot program utilizing the electronic Submission Template And Resource (eSTAR), originally developed by the FDA. The program allows manufacturers to prepare a single eSTAR submission package that can be used for premarket applications in both jurisdictions, targeting Class II, Class III, and certain Class IV medical devices under Canada’s Medical Devices Regulations. The primary goals are to reduce redundant effort, enhance submission quality, accelerate review processes, and promote regulatory convergence between the two agencies. Source: Notice to Industry: Health Canada – FDA eSTAR Pilot - Canada.ca
Scope and Eligibility
- Device Classes: Primarily Class II and Class III devices; select Class IV devices may be considered on a case-by-case basis.
- Submission Types: New licence applications, licence amendment applications, and (in some cases) administrative changes.
- Participation: Voluntary and limited to a defined number of submissions during the pilot phase.
- Exclusions: Devices requiring special regulatory pathways (e.g., emergency use authorizations) or those not suitable for eSTAR format are generally excluded.
Manufacturers interested in participating were required to contact Health Canada to express interest and confirm eligibility.
Key Features of eSTAR in the Pilot
- Single Template: One standardized electronic form covering both Canadian and U.S. requirements where possible, with agency-specific sections clearly identified.
- Interactive PDF Format: Structured, guided questions reduce errors and omissions; includes built-in help text and validation checks.
- Integrated Content: Supports attachment of supporting documents (e.g., risk management files, test reports, clinical data).
- Alignment Benefits: Facilitates simultaneous or sequential submission to both agencies using largely the same content, improving consistency of data presented.
Benefits for Industry and Regulators
- For Manufacturers: Reduced preparation time and duplication; clearer expectations through guided template; potential for faster market access in both countries.
- For Regulators: Improved submission quality and completeness; more efficient review due to standardized format; enhanced collaboration and learning between Health Canada and FDA.
Pilot Status and Next Steps
The pilot program was time-limited and intended to evaluate feasibility, usability, and impact on review timelines. Outcomes were expected to inform potential future adoption or expansion of eSTAR (or similar tools) in Canada’s regulatory framework. Manufacturers were encouraged to monitor updates from both agencies regarding continuation, modifications, or transition to routine use.
Detailed instructions for preparing eSTAR submissions, participation criteria, contact points, and examples of completed templates are provided in the official Health Canada notice on the joint eSTAR pilot with the FDA. Source: Notice to Industry: Health Canada – FDA eSTAR Pilot - Canada.ca
This initiative represents an important step toward greater regulatory cooperation and efficiency in medical device approvals between Canada and the United States.
Ask Anything
We'll follow up with you personally.
Related Articles
Approximately 5 minutes
Notice to Industry: Licensing Requirements for Medical Devices in Canada
Health Canada’s notice to industry clarifies licensing obligations for medical devices under the Medical Devices Regulations, emphasizing that most devices sold or imported into Canada require a valid medical device licence (except Class I devices), detailing application processes, timelines, and compliance expectations to ensure safety and effectiveness before market entry.
Approximately 5 minutes
Guidance on Determining Significant Changes to Licensed Medical Devices – Health Canada Interpretation
Health Canada’s guidance document interprets what constitutes a ‘significant change’ to a licensed medical device under the Medical Devices Regulations, requiring manufacturers to assess design, manufacturing, labelling, and intended use modifications against specified criteria to determine if a new licence application, amendment, or administrative update is necessary to maintain regulatory compliance and device safety.
Approximately 5 minutes
Canada’s Participation in the International Medical Device Regulators Forum (IMDRF)
Health Canada actively participates in the International Medical Device Regulators Forum (IMDRF), a voluntary group of medical device regulators from ten member countries working to accelerate international regulatory convergence, harmonize technical requirements, and promote global alignment on premarket and post-market oversight to improve patient access to safe and effective medical devices.
Approximately 5 minutes
Guidance on Cybersecurity for Medical Devices – Health Canada Expectations
Health Canada’s guidance outlines manufacturer expectations for incorporating cybersecurity throughout the medical device lifecycle, from design and risk management to post-market surveillance, emphasizing threat identification, secure architecture, vulnerability management, and secure updates to protect against cyber risks that could impact device safety and effectiveness.
Approximately 5 minutes
Interim Guidance on Importing and Manufacturing Medical Gowns During COVID-19 – Health Canada
Health Canada’s interim guidance during the COVID-19 pandemic outlined flexible pathways for importing and manufacturing medical gowns (isolation gowns) to address shortages, including acceptance of non-traditional suppliers, alternative standards, labelling flexibilities, and risk-based oversight while maintaining minimum safety and performance expectations for healthcare use.