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Personal Importation

Overview​

Individuals may personally import a small quantity of a medical device for their own personal use without the device requiring a Canadian Device Licence. This is sometimes called the "personal use exemption."

Conditions​

The personal importation pathway is generally accepted when:

  • The quantity is consistent with personal use (not for resale or commercial distribution)
  • The device is for the importer's own use or for immediate family members
  • The device is not on the Importation Prohibited list
  • The device does not pose an immediate serious health hazard

Common examples​

  • Travellers returning to Canada with a personal medical device (e.g., CPAP machine, glucose meter) purchased abroad
  • Patients importing a device not available in Canada for their specific condition
  • Patients with rare conditions importing a device used internationally but not licensed in Canada

Limits of personal importation​

Personal importation does not allow:

  • Import for distribution to others (even at no charge — this constitutes distributing, which requires an MDEL)
  • Import of large quantities beyond personal use
  • Import of devices that have been subject to a Health Canada safety advisory or recall in Canada

CBSA and Health Canada interaction​

Canada Border Services Agency (CBSA) enforces importation rules at the border. CBSA officers may refer questions about medical device importation to Health Canada. For unusual or high-value devices, contacting Health Canada's Medical Devices Directorate in advance is advisable.

Relationship to Special Access​

If a device is not personally importable and is also not licensed in Canada, the Special Access Program (SAP) may be the appropriate route for a healthcare practitioner to obtain the device for a specific patient. See Special Access Program.

Legislative source: Food and Drugs Act, RSC 1985, c F-27; Health Canada personal importation policy