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Learn about medical device inspections.
The Medical Devices Bureau of the Therapeutic Products Directorate (TPD) is the national authority that monitors and evaluates the safety, effectiveness and quality of diagnostic and therapeutic medical devices in Canada.
Medical devices included on this list are called "designated medical devices" and are eligible for the exceptional importation and sale provisions provided for in the Interim Order.
Medical devices that are eligible for importation and sale under the interim order (IO) are known as “designated” devices. They are included in the list of medical devices for exceptional importation and sale.
This guidance document is intended for any person in the medical device industry and it provides guidance on regulatory requirements in relation to Medical Device Establishment Licences (MDEL), including when and how to apply for an MDEL, and how to maintain an MDEL once issued.
List of medical device shortages related to COVID-19.
List of specified medical devices related to COVID-19.
Medical devices imported into Canada for sale, with or without a monetary contribution, must meet Health Canada requirements for commercial importation, as outlined in the Food and Drugs Act (FDA) and the Medical Devices Regulations (MDR).
A medical device shortage occurs when a manufacturer is unable to meet Canadian market demand for the device or for its components, accessories, parts or consumable materials. It does not include a situation in which a substitute device, component, accessory, or part is available.
Under the Interim Order, manufacturers and importers must report medical device shortages related to COVID-19 to Health Canada. The devices to which the shortages apply are on the List of Medical Devices — Notification of Shortages (specified medical devices).