Health Canada’s use of Interim Orders (IOs) has allowed for the exceptional importation and sale of Medical Devices (MDs) to help prevent shortages in relation to COVID-19. To date, Health Canada has published 3 separate IOs in relation to medical devices, the first on March 18, 2020, and the second on March 1, 2021. Interim Order Number 3 repeals and replaces Interim Order Number 2.

What does this mean?

For manufacturers and applicants:

• The intention for IO No. 3 is to maintain the same flexibilities offered under IO No. 2. Manufacturers of authorized devices under IO No. 2 can continue to import and sell MDs in Canada. MD applications made under IO No. 2 will be evaluated under IO No. 3. No action from the manufacturer is required.

For importers and distributors:

• MDs authorized under IO No. 2 can continue to be sold under IO No. 3. However, if you are an importer or distributor of an IO-authorized MD in Canada, you must obtain a Medical Device Establishment Licence (MDEL).

If you have any questions or concerns about Interim Order Number 3 or need assistance applying for a Medical Device Licence (MDL) or Medical Device Establishment Licence (MDEL) for your medical device, please contact dicentra.