Consultation: Proposed changes to the List of recognized standards for medical devices

Health Canada was seeking feedback on draft updates to the List of recognized standards for medical devices.

Following this consultation, Health Canada will be changing the process for updating the List of recognized standards for medical devices by introducing a continuous, year-round feedback approach. Stakeholders will be encouraged to share their input at any time by emailing standards.committee@hc-sc.gc.ca.

Feedback received will be compiled on an ongoing basis and incorporated into the annual review of the List of recognized standards. This approach supports more timely engagement, improves responsiveness to stakeholder input, and enables a streamlined process for delivering consistent annual updates.

Who was the focus of this consultation

We engaged with:

• manufacturers of medical devices
• regulatory representatives
• health care professionals

Key questions for discussion

Health Canada sought feedback on the proposed additions and deletions and updates in the draft List of recognized standards.

Specifically, if there are any items in the list that should have been added, removed or updated.

Related information

• Food and Drugs Act
• Medical Devices Regulations
• Guidance on using standards to support compliance with the Medical Devices Regulations

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