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..
