Health Canada’s Proposed Changes to Medical Device Standards Guidance

Health Canada has updated its list of recognized standards for medical devices and issued guidance on their use for compliance with the Medical Device Regulations. The consultation period for these updates is open for 60 days, from July 25, 2024, to September 23, 2024.

The updated list features a new method of version recognition, the addition of six new standards, updates to 12 existing standards with added notes, and the removal of 14 standards. The revised guidance document provides manufacturers with concepts for using standards to support compliance with the Regulations. It also clarifies how manufacturers can utilize the list of recognized standards and explains the new version recognition method.

Health Canada is seeking feedback on the clarity and understandability of the content in both the updated list and the guidance document. They are interested in comments on the standards that have been added, removed, or updated, and on any missing concepts or principles that require further explanation or clarification.

Source: https://www.canada.ca/en/health-canada/programs/consultation-updates-draft-guidance-list-recognized-standards-medical-devices/notice.html##~https://www.canada.ca/en/health-canada/programs/consultation-updates-draft-guidance-list-recognized-standards-medical-devices.html

Region: Canada