Notice on Health Canada's proposed changes to the guidance on recognized standards for medical devices
On this page
About the updates
Health Canada has updated the:
- List of recognized standards for medical devices and
- Guidance on using standards to support compliance with the Medical Device Regulations
The updated list has:
- a new method of version recognition using standards listed without years and editions
- 6 new standards
- 12 updated standards with notes added
We also removed 14 standards.
The updated guidance document:
- explains the concepts that manufacturers must apply when using standards to support compliance with the Medical Devices Regulations
- helps manufacturers understand how to use the list of recognized standards for medical devices
- explains the new method used for version recognition
About the consultation
We're looking for feedback on the updates made to the list and guidance from medical device manufacturers, regulatory affairs representatives in the field of medical devices and health care professionals.
First of all, we want your input on whether the content in both the list and guidance document are clear and understandable.
We also want to hear from you:
- about the standards that have been added, removed or updated in the list
- if a concept or principle is missing or needs to be better explained or clarified in the guidance document
We will finalize the list and guidance document based on the comments we receive.
The 60-day consultation period is from July 25 to September 23, 2024.
Share your views on the updated list of recognized standards for medical devices and draft guidance
Contact us
Medical Devices Directorate
Health Products and Food Branch
Health Canada
11 Holland Ave, Tower A
Address Locator: 3002A
Ottawa ON K1A 0K9
Email: Standards.Committee@hc-sc.gc.ca