Exceptional importation and sale of medical devices in relation to COVID-19: Overview

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There is an unprecedented demand and urgent need for access to medical devices during the COVID-19 pandemic. On March 1, 2021, the Minister of Health signed the Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19. The Interim Order (IO) repeals and replaces the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19. It extends measures introduced in the previous interim order allowing certain medical devices that may not fully meet regulatory requirements, but are manufactured to comparable standards, to be imported and sold.

An IO is one of the fastest mechanisms available to address large-scale public health emergencies, without following the usual regulatory processes. Further information on this Interim Order can be found in the Explanatory Note.

How to import and sell designated medical devices

Medical devices included on the List of Medical Devices for Exceptional Importation and Sale are called "designated medical devices" and are eligible for the exceptional importation and sale provisions provided for in the Interim Order. The list, which will be updated as required, is incorporated by reference in the IO and is maintained by Health Canada.

To submit proposals to add a medical device to the list, email the completed Medical devices for exceptional importation and sale request form and copies of labels to: medicaldevices.covid19.instrumentsmedicaux@hc-sc.gc.ca.

Health Canada will review the request and inform you of our decision to add to the list. Note: Health Canada may also add a product to the list without receiving a proposal.

Once on the list, importers must notify Health Canada using the Exceptional importation and sale notification form to import a designated device at least 5 calendar days before the day on which the device is imported. Notifications should be sent to: medicaldevices.covid19.instrumentsmedicaux@hc-sc.gc.ca.

Regulatory requirements for selling designated medical devices

Importers may bring designated medical devices into Canada without meeting some of the requirements under the Medical Devices Regulations. Sections 44 to 65.1 remain in effect even when a medical device is designated on the list.

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