On September 29, 2025, Health Canada announced an important development in its ongoing efforts to streamline medical device submissions. The agency is launching a second phase of the eSTAR pilot program, which broadens the range of submission types eligible for this electronic format. This update is critical for clinical, quality, and regulatory teams involved in medical device applications.
What changed?
The updated pilot program now accommodates additional types of medical device submissions. This evolution builds on the initial eSTAR pilot, which was limited to specific submission categories. The broader scope enables more manufacturers and applicants to leverage electronic templates designed to enhance efficiency and compliance.
Who is affected?
Manufacturers, regulatory affairs teams, and quality professionals seeking medical device approval in Canada are directly impacted. Organizations that previously did not qualify for the initial eSTAR pilot should review the new eligibility criteria, as more submission types are now included.
Benefits of the expanded pilot
Health Canada aims to reduce administrative burdens and error rates with the expanded eSTAR pilot. Specific advantages include:
- Streamlined submission process, minimizing repetitive documentation.
- Improved consistency in regulatory requirements adherence.
- Reduced review times due to pre-built electronic templates.
The electronic submission format also aligns with international regulatory efforts, further harmonizing compliance practices across borders.
FAQ
Q: What is eSTAR?
A: eSTAR, or electronic Submission Template and Resource, is a standardized electronic format for preparing medical device submissions. It helps applicants ensure regulatory compliance while improving submission quality.
Q: How can I participate in the pilot?
A: Interested parties should consult the Health Canada guidance documents or reach out directly to the agency for detailed eligibility criteria and submission guidelines.
Q: Does eSTAR apply to all device classifications?
A: Not all device classifications are included. Review the expanded criteria carefully to determine if your submission type qualifies.
Conclusion
The expansion of Health Canada's eSTAR pilot signifies a crucial step forward in modernizing medical device submission processes. Clinical, quality, and regulatory teams should familiarize themselves with the new scope and consider utilizing eSTAR for eligible applications. Staying informed is key to maintaining compliance and optimizing submission timeframes.
Disclaimer
This article is intended for informational purposes and does not constitute legal or regulatory advice. Readers should consult Health Canada's official resources or seek professional guidance specific to their submissions.
Health Canada's official link
For full information about the announcement, see the link below.