Health Canada and FDA eSTAR pilot
Pilot program between Health Canada and FDA for electronic submission and reporting (eSTAR) to improve regulatory efficiency and harmonization between Canadian and US medical device approval processes.
🔖 Status: in-development
This reform is part of Health Canada's ongoing programme to modernise and strengthen the Canada medical device regulatory framework. Monitor the official source for updates on timelines, consultation opportunities, and implementation guidance. Where relevant, begin assessing potential impacts on your existing registrations, technical documentation, and compliance timelines so your organisation is prepared when the reform takes effect.
View official source ↗