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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.

There is an unprecedented demand and urgent need for access to medical devices during the COVID-19 pandemic. On March 30, 2020, the Minister of Health signed the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19. The interim order (IO) allows certain medical devices that may not fully meet regulatory requirements to be imported and sold.

Health Canada's Medical Devices Regulations regulate traditional devices effectively. New technologies, such as software as a medical device, need more flexibility in our regulatory oversight.

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).

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).

Information about a medical device must be available and in a form that is accessible to users, to ensure it is used safely.

This guidance document outlines the information considered necessary to support the safety and effectiveness of chemical products that are represented for use as high-level disinfectants and sterilants on reusable semi-critical and critical medical devices, which are regulated as medical devices under the Medical Devices Regulations.

The Minister of Health, pursuant to subsection 30.1‍(1)Footnote(i) of the Food and Drugs Act Footnote(ii), makes the annexed Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19.

The term Medical Devices covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. This guide provides information on how medical devices are approved and authorized in Canada.