Canada – Notice on Health Canada’s proposed changes to the guidance on recognized standards for medical devices

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..