Health Canada has developed this guidance document in order to support the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 pursuant to subsection 30.1(1) of the Food and Drugs Act. This Interim Order will allow the Department to issue expedited authorization for sale or import of medical devices to deal with the current significant risk of COVID-19 to the health and safety of Canadians.
The Interim Order outlines Health Canada’s expectation and the information that is required to obtain authorization to import and sell COVID-19 medical devices in Canada. Importantly, an authorization under this Interim Order will be granted only if Health Canada determines that there is a public health need for the importation or sale of the COVID-19 medical device submitted.
The Interim Order provides an expedited authorization pathway for
- new COVID-19-medical devices that are not yet licensed in Canada or other jurisdictions,
- for COVID-19-related uses for existing devices licensed under the Medical Device Regulations, or under this Interim Order, and
- for COVID-19 medical devices that leverage an authorization of a device from a trusted foreign regulatory authority, whereby the Minister would maintain the ability to request additional information on a case-by-case basis.