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

From: Health Canada

On this page

• Who was the focus of this consultation
• Key items for discussion
• What was heard
• Next steps
• Contact us

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:

• medical device stakeholders
• medical device licence and establishment licence holders
• current authorization holders under Part 1.1

Key items for discussion

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

• if they would use this pathway to seek authorization for their product in response to an urgent public health need (UPHN) in the Canadian market
• the factors that will contribute to their decision to seek authorization under Part 1.1 versus Part 1 of the regulations
• if they had concerns about expanding Part 1.1 to help address any future public health emergency

We also wanted to hear about:

• challenges in complying with the requirements
• useful measures that may help overcome any challenges
• concerns on the impact of fees

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:

• Part 1.1 is a permanent pathway
• the criteria for identifying medical conditions and the number of medical conditions that a device could be used for under this pathway
• the process for amendment applications for Class I devices
• timelines and how applications will be prioritized

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:

• time to obtain market access
  • if there isn't a significant benefit in using Part 1.1, some stakeholders would prefer to apply for a medical device licence instead
• fees
  • the waiving of fees for UPHN medical devices appeals to foreign manufacturers who are competing in larger markets
• MDSAP certification
  • not having to obtain certification to market the device in an emergency situation is an incentive

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.

Contact us

Email: mddpolicy-politiquesdim@hc-sc.gc.ca