Consultation on amendments to regulations to import and sell COVID-19 medical devices

Current status: Closed

This consultation ran from May 2, 2022 to May 22, 2022.

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The purpose of this consultation was to engage with stakeholders on the proposed changes to the Medical Devices Regulations (MDR). Changes were proposed so that COVID-19 medical devices may continue to be imported and sold after the expiry of Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (IO No. 3).

We were also seeking feedback on the proposed changes and fee implications, outlined in the Notice of intent on the proposed changes to the MDR to continue the importation and sale of COVID-19 medical devices.

Who was the focus of this consultation

We engaged with:

Key items for discussion

We were seeking your feedback on the proposed measures and the fee implications outlined in the notice.

In particular:

We also wanted your ideas and input on the:

The input that was gathered through this process will help us refine the proposal and develop the related content.

What was heard

In general, stakeholders supported the proposed changes and no major concerns were raised. However, stakeholders sought clarification on the following items:

Stakeholders advocated for:

Next steps

Health Canada is grateful for the feedback received on the proposal. The feedback will help inform the guidance document that will accompany the regulations.

We will address process-based questions in the guidance document, which will be published at the same time as the regulatory package. For example:

Related information

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