On June 28, 2021, Health Canada opened a public consultation on a Unique Device Identification (UDI) system for medical devices in Canada. This is Health Canada’s first consultation on the UDI system for medical devices.
What is a Unique Device Identifier (UDI)?
A Unique Device Identifier (UDI) is a series of numeric or alphanumeric characters assigned to a specific medical device on the market and is created through globally accepted standards. A UDI code on a medical device allows tracing and tracking of the medical device through the healthcare system, from its entrance into the market through to its use in a patient.
What is the purpose of the consultation?
The purpose of the public consultation is to explore the feasibility of introducing a UDI system in Canada, including options for development of a UDI database by leveraging internal existing infrastructure. Health Canada proposes building 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. The focus of the public consultation is to seek feedback on:
- Introducing a Unique Device Identification (UDI) system for medical devices in Canada
- Who should be responsible for establishing and maintaining the Canadian UDI database
- The potential scope of regulatory and legislative amendments required to establish a UDI System in Canada
What is IMDRF and what do they do?
IMDRF stands for International Medical Device Regulators Forum. The International Medical Device Regulators Forum is a voluntary group of medical device regulators from around the world who work to support convergence in the area of medical device regulations. The International Medical Device Regulators Forum published the original guidance on a global Unique Device Identification System for Medical Devices in December of 2013. The guidance provides a high-level framework for how a globally harmonized device identification system should work.
According to the guidance document on UDI developed by the International Medical Device Regulators Forum, a UDI system must have three interrelated components:
- UDIs must be based on global standards;
- UDIs must be applied to the label of a medical device and its associated packaging; and
- Information about the medical device must be submitted to a UDI database for the purpose of data sharing amongst regulators and other healthcare stakeholders.
What will the feedback from this consultation be used for?
The feedback gathered through this public consultation 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 website.
What are the benefits of implementing a UDI system?
Implementing a UDI system in Canada will bring several benefits to industry, government, consumers, healthcare providers and the healthcare system, such as:
- More accurate reporting
- Reduced medical errors
- Collection of “real world data”
- Patients can track their own devices
- Effective management of medical device recalls
- Addressing counterfeiting and diversion of medical devices
Who should participate in the consultation?
Health Canada is seeking feedback from industry professionals, provinces and territories, health care organizations, and the general public.
Interested parties can participate in the public consultation. The consultation will close on September 30, 2021.
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