The intent of the e-learning course, Understanding How Medical Devices are Regulated in Canada – Medical Device Establishment Licensing and Post-market Regulation, is to help stakeholders understand Health Canada’s post-market regulatory requirements for medical devices, including topics such as Medical Device Establishment Licensing, Inspections and Compliance Verifications.

This Device Advice: e-Learning tool is intended to educate stakeholders on the premarket regulatory requirements for medical devices in Canada. Designed as an interactive learning platform, it covers a range of topics, including risk classification, licensing and labelling requirements, required submission documents, licence application types, licence amendments, and management of applications. This tool is recommended for various medical device stakeholders, including manufacturers, importers, distributors, consultants, healthcare groups and academia.