Regulations to allow exceptional importation of medical devices to address shortages as of March 2, 2022

Medical Devices Compliance Program Bulletin, February 16, 2022

Amendments to the Medical Devices Regulations (MDR), published in Canada Gazette, Part II in September 2021, come into force on March 2, 2022. The amendments will allow for the exceptional importation and sale of medical devices to help address shortages in Canada.

Current provisions allowing the exceptional importation and sale of devices related to COVID-19 are set out under Interim Order No. 2 respecting drugs, medical devices and foods for a special dietary purpose in relation to COVID-19. This interim order will no longer be in effect after March 1, 2022. Health Canada will remove products on the current List of medical devices for exceptional importation and sale at this time. We will then create a new list of designated medical devices.

The amendments to the MDR allow medical devices that would not otherwise meet Canada's regulatory requirements to be imported and sold. However, these devices must meet the following conditions:

• the device is a substitute for one that is in shortage or at risk of being in shortage
• the device is authorized for sale in another jurisdiction
• the device is manufactured to quality standards comparable to those in the MDR
• the importer has a medical device establishment licence (MDEL)
• the importer informs Health Canada at least 5 business days before importing the device

We will begin processing submissions under this new pathway on March 2, 2022.

Health Canada has published draft guidance for exceptional importation and sale of medical devices. You may send your comments on the draft guidance to us by February 21, 2022, by email: mdcu-ucim@hc-sc.gc.ca. We will post final guidance and application forms online on March 2, 2022.