Consultation on Unique Device Identification (UDI) system for medical devices in Canada

From: Health Canada

Current status: Open

Opened on June 28, 2021 and will close to new input on September 30, 2021.

This is Health Canada’s first consultation on the UDI system for medical devices. The input gathered through this process will be used to inform the assessment of options for the potential implementation of UDI in Canada and next steps. Should Health Canada choose to pursue a UDI system, there will be further consultation with stakeholders. Health Canada will share the results of this consultation in a timely manner on the Health Canada’s website.

We are exploring the feasibility of introducing a UDI system in Canada, including options for development of a UDI database by leveraging internal existing infrastructure. We propose to build on the work and experience of the International Medical Device Regulators Forum (IMDRF), as well as the United States Food and Drug Administration’s implementation to inform the principles and design of a UDI System for Canada.

We would like to hear from industry, provinces and territories, health care organizations, and the general public to ensure we work together on this important initiative.

The focus of this paper is to seek your feedback on:

Join in: how to participate

  1. Please read the Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Canada and respond to the questions below for stakeholders.
  2. Once you have prepared your responses, you can send them via email to Medical Device Directorate Policy at hc.mddpolicy-politiquesdim.sc@canada.ca with your responses, ideas and/or comments.

Who is the focus of this consultation

We will engage with:

Key questions for Stakeholders

We would like to hear from industry, provinces and territories, health care organizations, and the general public to ensure we work together on this important initiative.

  1. Do you support the establishment of a UDI system in Canada that is based on the IMDRF template?
  2. If the Canadian implementation fully aligns with the IMDRF guidance, what will the impact be?
  3. While it is highly desirable to align internationally, do you have proposals for possible exemptions from UDI requirements? Do you have comments on what devices should be exempt from UDI requirements? Do you agree with Health Canada’s proposal to exempt custom-made devices and Class I devices?
  4. It is proposed that Health Canada establish and manage the Canadian UDI database. Are there any concerns with this proposal? Are there alternative organizations that could establish and manage the Canadian UDI database? What are the advantages and disadvantages of these alternatives?
  5. Are there any other issues and questions we need to consider when implementing this change? Are there impacts to your organization of which you would like Health Canada to be aware?
  6. What core data elements and other relevant information should be entered into the Canadian UDI database?
  7. How should we link the Canadian UDI database to other related databases within the Canadian healthcare system?
  8. What impacts (financial or other) or obstacles do you anticipate for your organization and other stakeholders?
  9. What are the benefits of the Global Medical Device Nomenclature (GMDN) in your organizations, and how is it being used?
  10. What are the benefits of a Canadian UDI System for your organization and across the healthcare system?

The input gathered through this process will be used to inform the assessment of options for the potential implementation of UDI in Canada and next steps.

Contact us

Bureau of Policy and International Programs
Medical Devices Directorate
Health Products and Food Branch
Health Canada
Holland Cross-, Tower A
1600 Scott St.
Address Locator 3102C3
Ottawa, Ontario
K1A 0K9
Email: hc.mddpolicy-politiquesdim.sc@canada.ca

Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: