Importation and sale of medical devices for COVID-19 guidance document: Background
Health Canada has made the exceptional importation mechanism permanent by transitioning interim order provisions by amending the Food and Drug Regulations. The interim order expired on March 1, 2022. The new regulatory pathway for these products took effect on March 2, 2022. For more information, visit the new Regulations amending certain regulations concerning drugs and medical devices (shortages): Notice
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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 continue the response to this urgent need, the Minister of Health signed the Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 on March 1, 2021. The Interim Order (IO) replaces the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 signed on March 30, 2020.
The IO helps address shortages of products related directly or indirectly to the COVID-19 pandemic. It does this by providing an exceptional process for importing and selling such products, including medical devices.
Under the IO, medical devices that do not fully meet Canadian regulatory requirements, but are made to comparable standards, 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:
- personal protective equipment (PPE) that does not have compliant labelling
- PPE that is labelled with the distributor’s contact information instead of the manufacturer’s contact information
- Class II to IV devices that are licensed in Canada but are being imported with labelling from another jurisdiction
- products that have expired but show no signs of wear and whose expiration is not likely to impact safety
Note: The medical devices imported and sold under the IO are still subject to all of the regulatory requirements of the Medical Devices Regulations that pertain to:
- establishment licensing (sections 44 to 51.1)
- distribution records (section 52)
- complaint handling (section 57)
- mandatory problem reporting (sections 59 to 62)
- recalls (sections 63 to 65.1)
The applicable regulatory requirements are outlined in Health Canada’s guidance on medical device establishment licensing and fees.
About the guidance document
This guidance document is intended to help importers, distributors, manufacturers and other establishments meet their regulatory requirements, such as:
- requesting medical devices be put on the list of medical devices for exceptional importation and sale
- providing a notification of importation
- ensuring that information is accessible
It remains in effect as long as the IO is in effect.
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