Medical Device Establishment Licencing (MDEL)

View service inventory entry Visit service website Suggest a correction

Any person who imports into Canada, or sells in Canada, a medical device for human use requires an establishment licence (some exemptions apply). Health Canada reviews applications, verifies these applications against legal requirements, and makes decisions on applications. In addition, Health Canada monitors compliance and takes compliance and enforcement actions when required. - (ROEB) (Medical Devices, Health Canada.)

Back to Health Canada services