Health Canada Continues to Actively Monitor Supply of Medical Devices

By Anna Flotilda Desales, Tamara Schoyen, and Evangeline Loh

Legislative background on shortages

On March 2, 2022, amendments to the legislation in Canada, Medical Devices Regulations (SOR/98-282, Part 1, Sections 62.21 to 62.26) came into force. These provisions discuss the notification of shortages to the regulator Health Canada. If an explicit device is delineated on the “List of Medical Devices- Notification of Shortages” and the manufacturer or importer notes the shortage “exists or is likely to occur,” a report needs to be completed and information about the shortage provided. The legislation also permits voluntary notification. Reporting of medical device shortages applies to manufacturers of Class I-IV medical devices and importers of Class I devices. In addition, manufacturers or designated importers are required to report if the manufacturer is discontinuing the sale of a specified medical device in Canada and whether the discontinuation may cause a shortage.

Definition of shortage (and medical device discontinuation)

A shortage occurs when a medical device manufacturer is “unable to meet the demand for the device in Canada” (Interpretation, Definitions, Medical Devices Regulations). If the manufacturer decides to stop the sale of a device explicitly identified and this would lead to a shortage, this is a medical device discontinuation and there are also reporting requirements.

List of medical devices: notification of shortages

The Minister of Health actively adds and removes devices to the shortages list. In the past few months, four devices (March 7, 2025) have been removed (extracorporeal membrane oxygenation (ECMO), intra-aortic balloon catheters, intra-aortic balloon pumps (IABPs), and oxygen concentrators). Two devices were added (intravascular shunts (January 9, 2025) and urine/urinary drainage systems (December 24, 2024).

Currently, there are 20 devices delineated.

Concluding remarks

Health Canada actively monitors the supply of medical devices in Canada. As a medical device manufacturer marketing licensed Class II, III and IV medical devices in Canada, in addition to possessing a MDSAP certified Quality Management System and other regulatory compliance obligations, one must include within the Quality Management System processes related to monitoring the shortage list and reporting.

In addition to the regulatory compliance obligations for Medical Device Establishment License holders, Class I manufacturers and importers of Class I devices, must also confirm that they have processes in place to monitor the shortage list and reporting.

There is also a public list posted to the Health Canada website which may provide insight for competitors of similar devices. Companies may refer to Health Canada’s Guide to reporting medical device shortages and discontinuations for additional information.