Suspension & Cancellation

Device Licence suspension

Health Canada may suspend a Device Licence when:

• The licence holder fails to pay annual fees within the required period
• The licence holder is found to be non-compliant with the MDR following an inspection or investigation
• The device is found to pose a safety risk requiring immediate market withdrawal pending further investigation

A suspended Device Licence means the device cannot be sold in Canada. The licence holder must resolve the issue leading to suspension before the licence can be reinstated.

Device Licence cancellation

A Device Licence may be cancelled when:

• The manufacturer requests cancellation (e.g., voluntarily withdrawing the product from the Canadian market)
• Health Canada cancels the licence following a finding of serious non-compliance
• The licence holder has failed to respond to Health Canada's requests for corrective action
• Post-market evidence demonstrates the device is unsafe or ineffective

Once a licence is cancelled, the device is removed from the MDALL database and cannot be legally sold in Canada. Any remaining distributed stock should be addressed through the recall/FSCA process.

MDEL suspension and cancellation

Similar provisions apply to MDELs. Non-payment of annual fees or failure to comply with MDR requirements can result in MDEL suspension or cancellation, prohibiting importing or distributing activities.

Consequences

Consequence	Suspended licence	Cancelled licence
Device can be sold in Canada	No	No
Post-market obligations continue	Yes	Yes (for distributed stock)
Licence can be reinstated	Yes (upon compliance)	May require new application

Legislative source: Medical Devices Regulations, SOR/98-282, ss 43–43.1 (suspension/cancellation)