The purpose of this letter is to provide a high-level overview of the proposed new interim order and proposed transition regulations being developed by Health Canada.
Background
The Interim Order respecting the importation and sale of medical devices for use in relation to COVID-19 (the IO) is set to expire in March 2021. It provides a faster way to authorize the importation and sale in Canada of medical devices that are used to diagnose, treat, mitigate or prevent COVID-19. With the COVID-19 pandemic still ongoing, Health Canada intends to maintain the flexibilities and regulatory oversight provided by the IO through a second interim order that would last until at least fall 2021 (the end of the interim order period).
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