Closed consultation: Proposed changes to the Medical Devices Regulations to address future public health emergencies

Current status: Closed

This consultation ran from March 23, 2023, and closed on April 13, 2023.

On this page

We consulted stakeholders on the proposed changes to the Medical Devices Regulations (regulations). We had proposed expanding Part 1.1 of the regulations to address any future public health emergency, not just COVID-19. We outlined the proposed changes and fee implications in a notice of intent.

Who was the focus of this consultation

We engaged with:

Key items for discussion

We sought comments on the proposed measures and fee implications. In particular, we wanted stakeholders to tell us:

We also wanted to hear about:

What was heard

In general, stakeholders supported the proposed changes to expand Part 1.1 to future public health emergencies. They did not have any major concerns.

Stakeholders did want to clarify:

We also received feedback on the requirements related to the Medical Device Single Audit Program (MDSAP) certificate under Part 1.1 and associated fees. To maintain and ensure quality standards for medical devices under Part 1.1, we're not proposing to make changes to the proposal as a result of the feedback. To maintain their COVID-19 authorization, manufacturers of Class II to IV devices must meet the MDSAP certification requirement under Part 1.1 after their device is removed from the UPHN list.

Stakeholders also commented that some factors that could contribute to a decision to seek authorization under Part 1.1 versus Part 1 of the regulations. These factors included:

Next steps

Health Canada appreciates the feedback we received. We will use this feedback, including comments asking for clarification, to develop the guidance document. The guidance document will be published at the same time as the regulatory package.

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