Share your views: Draft Pre-market guidance for machine learning-enabled medical devices
Consultation seeking public input on draft pre-market guidance for machine learning-enabled medical devices. Addresses regulatory pathway and requirements for AI/ML-based medical devices.
Health canada is inviting written submissions from manufacturers, sponsors, importers, and other industry stakeholders. Review the draft guidance or proposal at the official source, prepare comments identifying any practical impacts on your operations or products, and submit. Active participation helps ensure the final guidance reflects industry realities and gives your organisation early visibility of upcoming requirements.
View official source ↗