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Actions Against Non-Compliant Devices

Types of non-compliant device actions​

When Health Canada identifies a non-compliant or unsafe device on the Canadian market, it may take one or more of the following actions:

Public advisory​

Health Canada issues a public health advisory when there is an immediate risk to patients or the public. Advisories are published on the Recalls and Safety Alerts database and distributed through media channels.

Recall​

Health Canada coordinates with the manufacturer or importer to initiate a recall. If voluntary action is not taken, Health Canada may issue a mandatory recall order under Section 21.3 of the FDA. See Recalls & Field Safety.

Import alert​

Health Canada may place an import alert on a specific manufacturer, product, or lot, directing CBSA to detain shipments at the border pending inspection or testing.

Stop sale order​

A Section 21 order directing the regulated party to stop selling the device in Canada pending resolution of the compliance issue.

Device seizure​

Health Canada inspectors may seize devices under Section 23 of the FDA. Seized devices are held pending investigation and may be ordered destroyed if found non-compliant.

Public notifications​

All Health Canada actions against non-compliant devices (recalls, advisories, stop-sale orders) are published on the Recalls and Safety Alerts database: healthycanadians.gc.ca/recall-alert-rappel-avis

Healthcare facilities and distributors should monitor this database regularly.

Affected party responsibilities​

Manufacturers, importers, and distributors that receive a Health Canada compliance order must:

  • Respond promptly within the required timeframe
  • Implement corrective actions as directed
  • Report progress to Health Canada
  • Maintain records of all compliance activities

Non-response or inadequate response may escalate the enforcement action.

Legislative source: Food and Drugs Act, RSC 1985, c F-27, ss 21–23 (enforcement powers)