Canada – Importation and sale of medical devices for COVID-19 guidance document

COVID-19 is the infectious disease caused by coronavirus, SARS-CoV-2. The World Health Organization (WHO) declared a global pandemic related to COVID-19 on March 11, 2020.

The COVID-19 pandemic has created an unprecedented demand and urgent need for access to medical devices.

To respond to this urgent need, the Minister of Health signed the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 on March 30, 2020.

The interim order (IO) helps address shortages of products related directly or indirectly to the COVID-19 pandemic. It does this by providing an expedited process for the importation and sale of such products including medical devices.

Under the IO, medical devices that do not fully meet Canadian regulatory requirements are allowed to be imported into or manufactured for sale in Canada. Products that do not meet Canadian regulatory requirements but would be eligible for exceptional importation or sale may include…