Ensuring predictability for interim orders relating to COVID-19: Notice to stakeholders
From: Health Canada
On February 22, 2023, Health Canada introduced the Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19). These Regulations accelerate access to COVID-19 medical devices that have an urgent public health need in Canada. They also make it possible to continue to import and sell COVID-19 medical devices authorized under the interim order. For more information, please refer to the notice on Amendments to Medical Devices Regulations to continue importation and sale of COVID-19 medical devices and guidance on Medical devices for use in relation to COVID-19.
Health Canada understands that stakeholders need predictability with respect to the interim orders relating to COVID-19.
The purpose of this notice is to advise stakeholders that Health Canada intends to:
- maintain the flexibilities and regulatory oversight provided by the interim orders until at least the fall of 2021
- bring forward regulatory amendments that would allow many of the flexibilities under the Interim Orders to continue after the fall of 2021
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Since March 2020, Health Canada has put in place 5 interim orders (IO) to respond to the urgent need for access to health products as a result of the COVID-19 pandemic:
- Interim order - importation and sale of medical devices
- Interim order - permitting exceptional importation of key products
- Interim order - clinical trials for medical devices and drugs
- Interim order - importation, sale and advertising of drugs
- Interim order - prevention and alleviation of drug shortages
An IO is one of the fastest mechanisms available to the federal government to help make health products available to address larger-scale public health emergencies.
Health Canada intends to maintain the flexibilities and regulatory oversight provided by the interim orders until at least the fall of 2021.
By then, we intend to bring forward regulatory amendments that would allow many of the flexibilities under the interim orders to continue after the fall of 2021.
Health Canada will consult with interested industry stakeholders, health system partners and other government departments on the proposed regulations in the coming months. This notice will be updated with links to notices on these consultations, and any related measures, as they occur.
For more information, please contact us by email at email@example.com.
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