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Compliance & Enforcement

Health Canada's graduated response​

Health Canada takes a graduated approach to compliance and enforcement, generally escalating through progressively stronger tools before resorting to prosecution.

Compliance tools​

1. Warning letters / compliance letters​

Initial tool for addressing non-compliance. The company receives a written notice identifying the deficiency and requiring corrective action within a specified timeframe.

2. Compliance meeting​

Health Canada may request a meeting to discuss non-compliance and agree on corrective actions. Useful where the issues are complex or require negotiation on timelines.

3. Voluntary compliance undertaking​

A formal written commitment by the regulated party to take specific corrective actions by specific dates.

4. Section 21 order — stop sale​

Under Section 21 of the FDA, Health Canada may order a person to stop selling a device if it presents a risk of injury to health. A stop-sale order is published publicly.

5. Mandatory recall (Section 21.3 order)​

Health Canada may mandate a recall if a manufacturer or importer fails to act voluntarily when a safety issue is identified. See Health Canada-Initiated Recalls.

6. Device Licence or MDEL suspension/cancellation​

For serious or persistent non-compliance, Health Canada may suspend or cancel a Device Licence or MDEL.

7. Seizure of devices (Section 23)​

Health Canada inspectors may seize devices at the border or in distribution that are believed to be non-compliant or unsafe.

8. Prosecution​

For serious violations, Health Canada may refer the matter to the Public Prosecution Service of Canada. Offences under the FDA carry significant fines and/or imprisonment. Prosecution is reserved for the most serious cases.

Cooperation with international partners​

Health Canada shares compliance intelligence with:

  • US FDA
  • TGA (Australia)
  • EU competent authorities
  • MDSAP jurisdictions

A compliance action by one jurisdiction may trigger surveillance in others.

Legislative source: Food and Drugs Act, RSC 1985, c F-27, ss 21–32 (enforcement)