Health Canada has opened a public consultation on proposed changes to the List of Recognized Standards for medical devices. The consultation opened on July 27, 2026, and will remain open to new input until September 25, 2026. Health Canada is inviting feedback from manufacturers of medical devices, regulatory representatives, and health care professionals.
The List of Recognized Standards identifies the national and international standards that Health Canada formally accepts as evidence of compliance with the Medical Devices Regulations.When a standard is recognized, manufacturers can reference it in a device licence application to demonstrate that a specific regulatory requirement has been met.
Proposed additions, deletions, and updates to this list can directly affect how companies substantiate safety and effectiveness in their submissions.
How to Participate
Health Canada has released a draft version of the updated list and wants to know whether any items in it should be added, removed, or updated. The agency has outlined two ways for stakeholders to take part in this consultation:
- Review the draft list of recognized standards alongside the current recognized standards list to identify differences relevant to your product lines.
- Submit comments by emailing standards.committee@hc-sc.gc.ca before the consultation closes on September 25, 2026.
A Shift to Continuous Feedback
Beyond this specific round of proposed changes, Health Canada has signaled a broader change to how it manages the recognized standards list.
Rather than relying solely on periodic consultations, the department plans to introduce a continuous, year-round feedback process. Stakeholders will be able to submit input on recognized standards at any time through the same email address, standards.committee@hc-sc.gc.ca.
Feedback submitted through this ongoing channel will be compiled and folded into an annual review of the list, rather than requiring stakeholders to wait for the next formal consultation window.
Who Should Pay Attention
Health Canada has named three groups as the focus of this consultation: manufacturers of medical devices, regulatory representatives, and health care professionals.
In practice, this is most relevant to regulatory affairs teams managing active device licence applications or technical files, particularly where those files reference a standard that appears on the draft list for removal or modification.
Why This Is Worth Reviewing Now
Public consultations like this one are one of the few points in the regulatory process where industry has a direct opportunity to shape the outcome before it is finalized.
Reviewing the draft list now, while the comment period is open, gives regulatory teams time to identify standards relevant to their product lines and raise concerns directly with Health Canada, rather than adapting after changes are already in effect.
Frequently Asked Questions
When does the consultation close?
The consultation opened July 27, 2026, and closes to new input on September 25, 2026.
How do I submit feedback?
Comments can be submitted by emailing standards.committee@hc-sc.gc.ca with input on the proposed additions, deletions, and updates in the draft list.
Where can I find the proposed changes?
Health Canada has published a draft list of recognized standards, which can be compared against the current recognized standards list.
Does this consultation replace the annual review process?
No. Health Canada has stated that feedback, whether submitted during this consultation or through the new continuous channel going forward, will be compiled and incorporated into the annual review of the recognized standards list.
Who is Health Canada seeking input from?
The consultation is focused on manufacturers of medical devices, regulatory representatives, and health care professionals.
Key Takeaways
- Health Canada opened a public consultation on July 27, 2026, on proposed changes to the List of Recognized Standards for medical devices, closing September 25, 2026.
- Feedback can be submitted by email to standards.committee@hc-sc.gc.ca.
- Stakeholders are encouraged to compare the draft list against the current list to identify proposed additions, removals, and updates relevant to their products.
- Health Canada is introducing a continuous, year-round feedback process going forward, with input compiled into an annual review of the list.
- The consultation is focused on manufacturers, regulatory representatives, and health care professionals.
Conclusion
Health Canada’s consultation on the List of Recognized Standards for medical devices gives industry a direct window to weigh in before the list is finalized, and it marks a shift toward a more continuous feedback process going forward.
For regulatory affairs teams with active submissions or technical files, reviewing the draft list before September 25, 2026 is worth the time. Quality Smart Solutions supports companies through the full scope of Canadian medical device compliance, including how proposed standard changes may affect existing submissions. If you’re working through what these proposed changes could mean for your device submissions, our team can help you assess your regulatory position.
